Method and system for controlling ear stimulation

ABSTRACT

Systems and related methods for controlling delivery of a stimulus to a pinna of a subject with a stimulator worn on the pinna are described. A wearable stimulation device includes a mechanical, electrical, or other type of stimulator secured to a pinna of a subject. A personal computing device in communication with the wearable stimulation device controls delivery of stimuli and other aspects of operation of the device. In some aspects recommendations regarding neural stimuli and other stimuli or experiences to be delivered in association with the neural stimuli are provided via a computing system in communication with the personal computing device or the wearable stimulation device

If an Application Data Sheet (ADS) has been filed on the filing date ofthis application, it is incorporated by reference herein. Anyapplications claimed on the ADS for priority under 35 U.S.C. §§119, 120,121, or 365(c), and any and all parent, grandparent, great-grandparent,etc. applications of such applications, are also incorporated byreference, including any priority claims made in those applications andany material incorporated by reference, to the extent such subjectmatter is not inconsistent herewith.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application claims the benefit of the earliest availableeffective filing date(s) from the following listed application(s) (the“Priority Applications”), if any, listed below (e.g., claims earliestavailable priority dates for other than provisional patent applicationsor claims benefits under 35 USC §119(e) for provisional patentapplications, for any and all parent, grandparent, great-grandparent,etc. applications of the Priority Application(s)).

PRIORITY APPLICATIONS

None.

If the listings of applications provided above are inconsistent with thelistings provided via an ADS, it is the intent of the Applicant to claimpriority to each application that appears in the DomesticBenefit/National Stage Information section of the ADS and to eachapplication that appears in the Priority Applications section of thisapplication.

All subject matter of the Priority Applications and of any and allapplications related to the Priority Applications by priority claims(directly or indirectly), including any priority claims made and subjectmatter incorporated by reference therein as of the filing date of theinstant application, is incorporated herein by reference to the extentsuch subject matter is not inconsistent herewith.

SUMMARY

In an aspect, a neural stimulation system includes, but is not limitedto, a neural signal sensor adapted to sense a neural signal from asubject, the neural signal indicative of a physiological status of thesubject, a neural stimulator adapted to produce a stimulus responsive tothe sensed neural signal, the stimulus configured to activate at leastone sensory nerve fiber innervating at least a portion of a pinna of thesubject, and a securing member configured to secure the neuralstimulator to the pinna. In addition to the foregoing, other systemaspects are described in the claims, drawings, and text forming a partof the disclosure set forth herein.

In an aspect, a method includes, but is not limited to, sensing with aneural signal sensor a neural signal indicative of a physiologicalstatus of a subject, the neural signal sensor located in or on a portionof a body of the subject, determining with signal analysis circuitry atleast one parameter of the sensed neural signal, and delivering a neuralstimulus with a neural stimulation device worn on a pinna of the subjectresponsive to the sensed neural signal, wherein the neural stimulus isconfigured to modulate the activity of at least one sensory nerve fiberinnervating at least a portion of the pinna of the subject. In additionto the foregoing, other method aspects are described in the claims,drawings, and text forming a part of the disclosure set forth herein.

A wearable neural stimulation device includes, but is not limited to, avibratory mechanical stimulator adapted to produce a vibratory stimulusof sufficient frequency and amplitude to modulate the activity of atleast one mechanoreceptor with a receptive field on at least a portionof a pinna of a subject, and a securing member configured to secure thevibratory mechanical stimulator to the pinna. In addition to theforegoing, other device aspects are described in the claims, drawings,and text forming a part of the disclosure set forth herein.

In an aspect, a method includes, but is not limited to, delivering avibratory mechanical stimulus to at least a portion of a pinna of asubject with a neural stimulation device worn on the pinna of thesubject, wherein the vibratory mechanical stimulus is of sufficientfrequency and amplitude to modulate the activity of at least onemechanoreceptor with a receptive field on the at least a portion of thepinna. In addition to the foregoing, other method aspects are describedin the claims, drawings, and text forming a part of the disclosure setforth herein.

In an aspect, a neural stimulation system includes, but is not limitedto, a wearable neural stimulation device and a personal computingdevice, the wearable neural stimulation device including a neuralstimulator adapted to produce a stimulus for activating at least onesensory nerve fiber innervating at least a portion of a pinna of asubject, a securing member configured to secure the neural stimulator tothe pinna, control circuitry incorporated into the wearable neuralstimulation device for controlling operation of the neural stimulator,and first communication circuitry incorporated into the wearable neuralstimulation device and operatively connected to the control circuitry,the first communication circuitry configured for at least one of sendinga signal to and receiving a signal from a personal computing device; andthe personal computing device including a user interface for at leastone of presenting information to and receiving information from a user,control circuitry operatively connected to the user interface, secondcommunication circuitry configured for at least one of sending a signalto and receiving a signal from the first communication circuitry, andinstructions that when executed on the personal computing device causethe personal computing device to perform at least one of sending asignal to and receiving a signal from the wearable neural stimulationdevice via the second communication circuitry. In addition to theforegoing, other system aspects are described in the claims, drawings,and text forming a part of the disclosure set forth herein.

In an aspect, a system includes, but is not limited to, a personalcomputing device comprising circuitry for receiving a neural activitysignal, the neural activity signal indicative of a physiological statusof a subject, circuitry for determining a neural stimulus control signalbased at least in part on the neural activity signal, and circuitry foroutputting the neural stimulus control signal to a neural stimulationdevice including an external neural stimulator configured to be carriedon a pinna of the subject, wherein the neural stimulus control signal isconfigured to control delivery of a neural stimulus by the externalneural stimulator, the neural stimulus configured to activate at leastone sensory nerve fiber innervating at least a portion of the pinna. Inaddition to the foregoing, other system aspects are described in theclaims, drawings, and text forming a part of the disclosure set forthherein.

In an aspect, a method includes, but is not limited to, receiving aneural activity signal at a personal computing device, the neuralactivity signal indicative of a physiological status of a subject,determining a neural stimulus control signal based at least in part onthe neural activity signal, and outputting the neural stimulus controlsignal from the personal computing device to a neural stimulation deviceincluding an external neural stimulator configured to be carried on apinna of the subject, wherein the neural stimulus control signal isconfigured to control delivery of a neural stimulus by the externalneural stimulator, the neural stimulus configured to activate at leastone sensory nerve fiber innervating at least a portion of the pinna. Inaddition to the foregoing, other method aspects are described in theclaims, drawings, and text forming a part of the disclosure set forthherein.

In an aspect, a computer program product includes, but is not limitedto, a non-transitory signal-bearing medium bearing one or moreinstructions for receiving a neural activity signal, the neural activitysignal indicative of a physiological status of a subject, one or moreinstructions for determining a neural stimulus control signal based atleast in part on the neural activity signal, and one or moreinstructions for outputting the neural stimulus control signal to aneural stimulation device including an external neural stimulatorconfigured to be carried on a pinna of the subject, wherein the neuralstimulus control signal is configured to control delivery of a neuralstimulus by the external neural stimulator, the neural stimulusconfigured to activate at least one sensory nerve fiber innervating atleast a portion of the pinna. In addition to the foregoing, otheraspects of a computer program product are described in the claims,drawings, and text forming a part of the disclosure set forth herein.

In an aspect, a method includes, but is not limited to receiving aphysiological activity signal at a personal computing device, thephysiological activity signal indicative of a physiological status of asubject, determining a neural stimulus control signal based at least inpart on the physiological activity signal, outputting the neuralstimulus control signal from the personal computing device to a neuralstimulation device including an external neural stimulator configured tobe carried on a pinna of the subject, wherein the neural stimuluscontrol signal is configured to control delivery of a neural stimulus bythe external neural stimulator, the neural stimulus configured toactivate at least one sensory nerve fiber innervating at least a portionof the pinna, and presenting information to the subject via a userinterface. In addition to the foregoing, other method aspects aredescribed in the claims, drawings, and text forming a part of thedisclosure set forth herein.

In an aspect, a system includes, but is not limited to a personalcomputing device including circuitry for receiving a physiologicalactivity signal at a personal computing device, the physiologicalactivity signal indicative of a physiological status of a subject,circuitry for determining a neural stimulus control signal based atleast in part on the physiological activity signal, the neural stimuluscontrol signal is configured to control delivery of a neural stimulus bythe external neural stimulator, the neural stimulus configured toactivate at least one sensory nerve fiber innervating at least a portionof the pinna, circuitry for outputting the neural stimulus controlsignal from the personal computing device to a neural stimulation deviceincluding an external neural stimulator configured to be carried on apinna of the subject, and circuitry for presenting information to thesubject via a user interface. In addition to the foregoing, otherpersonal computing device aspects are described in the claims, drawings,and text forming a part of the disclosure set forth herein.

In an aspect, a computer program product includes, but is not limitedto, a non-transitory signal-bearing medium bearing one or moreinstructions for receiving a physiological activity signal, thephysiological activity signal indicative of a physiological status of asubject, one or more instructions for determining a neural stimuluscontrol signal based at least in part on the physiological activitysignal, one or more instructions for outputting the neural stimuluscontrol signal to a neural stimulation device including an externalneural stimulator configured to be carried on an ear of a subject,wherein the neural stimulus control signal is configured to controldelivery of a neural stimulus by the external neural stimulator, theneural stimulus configured to activate at least one sensory nerve fiberinnervating at least a portion of the pinna, and one or moreinstructions for presenting information to the subject via a userinterface. In addition to the foregoing, other computer program productaspects are described in the claims, drawings, and text forming a partof the disclosure set forth herein.

In an aspect, a system includes, but is not limited to a personalcomputing device including circuitry for receiving a physiologicalactivity signal at a personal computing device, the physiologicalactivity signal indicative of a physiological status of a subject,circuitry for determining a neural stimulus control signal based atleast in part on the physiological activity signal, circuitry foroutputting the neural stimulus control signal from the personalcomputing device to a neural stimulation device including an externalneural stimulator configured to be carried on a pinna of the subject,wherein the neural stimulus control signal is configured to controldelivery of a neural stimulus by the external neural stimulator, theneural stimulus configured to activate at least one sensory nerve fiberinnervating at least a portion of the pinna, and circuitry foroutputting an audio output signal via an audio output of the personalcomputing device. In addition to the foregoing, other system aspects aredescribed in the claims, drawings, and text forming a part of thedisclosure set forth herein.

In an aspect, a method includes, but is not limited to, receiving aphysiological activity signal at a personal computing device, thephysiological activity signal indicative of a physiological status of asubject, determining a neural stimulus control signal based at least inpart on the physiological activity signal, outputting the neuralstimulus control signal from the personal computing device to a neuralstimulation device including an external neural stimulator configured tobe carried on a pinna of the subject, wherein the neural stimuluscontrol signal is configured to control delivery of a neural stimulus bythe external neural stimulator, the neural stimulus configured toactivate at least one sensory nerve fiber innervating at least a portionof the pinna, and outputting an audio output signal via an audio outputof the personal computing device. In addition to the foregoing, othermethod aspects are described in the claims, drawings, and text forming apart of the disclosure set forth herein.

In an aspect, a computer program product includes, but is not limitedto, a non-transitory signal-bearing medium bearing one or moreinstructions for receiving a physiological activity signal at a personalcomputing device, the physiological activity signal indicative of aphysiological status of a subject, one or more instructions fordetermining a neural stimulus control signal based at least in part onthe physiological activity signal, one or more instructions foroutputting the neural stimulus control signal from the personalcomputing device to a neural stimulation device including an externalneural stimulator configured to be carried on a pinna of the subject,wherein the neural stimulus control signal is configured to controldelivery of a neural stimulus by the external neural stimulator, theneural stimulus configured to activate at least one sensory nerve fiberinnervating at least a portion of the pinna, and one or moreinstructions for outputting an audio output signal via an audio outputof the personal computing device. In addition to the foregoing, othercomputer program product aspects are described in the claims, drawings,and text forming a part of the disclosure set forth herein.

In an aspect, a method includes, but is not limited to, determining avibratory stimulus control signal with stimulation control circuitry ina personal computing device, and outputting the vibratory stimuluscontrol signal from the personal computing device to a wearablemechanical stimulation device including a vibratory mechanicalstimulator configured to be carried on a pinna of a subject, wherein thevibratory stimulus control signal is configured to control delivery of avibratory stimulus by the vibratory mechanical stimulator, the vibratorystimulus configured to activate at least one mechanoreceptor with areceptive field on at least a portion of the pinna. In addition to theforegoing, other method aspects are described in the claims, drawings,and text forming a part of the disclosure set forth herein.

In an aspect, a system includes, but is not limited to, a personalcomputing device including circuitry for determining a vibratorystimulus control signal, and circuitry for outputting the vibratorystimulus control signal to a wearable mechanical stimulation deviceincluding a vibratory mechanical stimulator configured to be carried ona pinna of a subject, wherein the vibratory stimulus control signal isconfigured to control delivery of a vibratory stimulus by the vibratorymechanical stimulator, the vibratory stimulus configured to activate atleast one mechanoreceptor with a receptive field on at least a portionof the pinna. In addition to the foregoing, other system aspects aredescribed in the claims, drawings, and text forming a part of thedisclosure set forth herein.

In an aspect, a computer program product includes, but is not limitedto, a non-transitory signal-bearing medium bearing one or moreinstructions for determining a vibratory stimulus control signalconfigured to control delivery of a vibratory stimulus by a vibratorymechanical stimulator, the vibratory stimulus configured to activate atleast one mechanoreceptor with a receptive field on at least a portionof a pinna of a subject, and one or more instructions for outputting thevibratory stimulus control signal to a wearable mechanical stimulationdevice including the least one vibratory mechanical stimulator. Inaddition to the foregoing, other computer program product aspects aredescribed in the claims, drawings, and text forming a part of thedisclosure set forth herein.

In an aspect, a method includes, but is not limited to, receivingidentifying information at a computing system, the identifyinginformation identifying at least one of a subject and a neuralstimulation device associated with the subject, the neural stimulationdevice configured to be carried on an ear of a subject and including anexternal neural stimulator, and transmitting a recommendation relatingto a treatment regimen from the computing system to a personal computingdevice used by the subject, the treatment regimen including delivery ofa neural stimulus to the subject with the external neural stimulator,the neural stimulus configured to activate at least one sensory nervefiber innervating skin on or in the vicinity of the ear of the subject.In addition to the foregoing, other method aspects are described in theclaims, drawings, and text forming a part of the disclosure set forthherein.

In an aspect, a system includes, but is not limited to, circuitry forreceiving identifying information identifying at least one of a subjectand a neural stimulation device associated with the subject, the neuralstimulation device configured to be carried on an ear of a subject andincluding an external neural stimulator, and circuitry for providing arecommendation relating to a treatment regimen to the subject, thetreatment regimen including delivery of a neural stimulus to the subjectwith the external neural stimulator, the neural stimulus configured toactivate at least one sensory nerve fiber innervating skin on or in thevicinity of the ear of the subject. In addition to the foregoing, othersystem aspects are described in the claims, drawings, and text forming apart of the disclosure set forth herein.

In an aspect, a computer program product includes, but is not limitedto, a non-transitory signal-bearing medium bearing one or moreinstructions for receiving identifying information identifying at leastone of a subject and a neural stimulation device associated with thesubject, the neural stimulation device configured to be carried on anear of a subject and including an external neural stimulator, and one ormore instructions for providing a recommendation relating to a treatmentregimen to the subject, the treatment regimen including delivery of aneural stimulus to the subject with the external neural stimulator, theneural stimulus configured to activate at least one sensory nerve fiberinnervating skin on or in the vicinity of the ear of the subject. Inaddition to the foregoing, other computer program product aspects aredescribed in the claims, drawings, and text forming a part of thedisclosure set forth herein.

The foregoing summary is illustrative only and is not intended to be inany way limiting. In addition to the illustrative aspects, embodiments,and features described above, further aspects, embodiments, and featureswill become apparent by reference to the drawings and the followingdetailed description.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 is an illustration of the external anatomy of the ear of a human.

FIG. 2A is an illustration of a system including a neural stimulationdevice worn on the ear of a subject.

FIG. 2B is a block diagram of the system of FIG. 2A.

FIG. 3 depicts a stimulation device including a securing memberconfigured to fit in the concha, and a clip securing member.

FIG. 4A depicts a stimulation device including a hanger-style securingmember.

FIG. 4B depicts the stimulation device of FIG. 4A positioned on an ear.

FIG. 5 depicts an embodiment of a stimulation device.

FIG. 6 depicts an embodiment of a stimulation device.

FIG. 7 is a block diagram of a neural stimulation system.

FIG. 8 is a block diagram of a computing system.

FIG. 9 is a flow diagram of a method.

FIG. 10 is a block diagram of a neural stimulation device.

FIG. 11 is a flow diagram of a method.

FIG. 12 is a block diagram of a neural stimulation system.

FIG. 13 is a block diagram of a system including a personal computingdevice.

FIG. 14 is a flow diagram of a method.

FIG. 15 is a block diagram of a computer program product relating to themethod of FIG. 14.

FIG. 16 is a block diagram of a system including a personal computingdevice.

FIG. 17 is a flow diagram of a method.

FIG. 18 is a block diagram of a computer program product relating to themethod of FIG. 17.

FIG. 19 is a block diagram of a system including a personal computingdevice.

FIG. 20 is a flow diagram of a method.

FIG. 21 is a block diagram of a computer program product relating to themethod of FIG. 20.

FIG. 22 is a block diagram of a system including a personal computingdevice.

FIG. 23 is a flow diagram of a method.

FIG. 24 is a block diagram of a computer program product relating to themethod of FIG. 23.

FIG. 25 is a block diagram of a system relating to operation of a neuralstimulation device.

FIG. 26 depicts data aspects relating to FIG. 25.

FIG. 27 is a flow diagram of a method.

FIG. 28 is block diagram of a computer program product relating to themethod of FIG. 27.

FIG. 29 is an illustration of an embodiment of a system for deliveringneural stimulation in combination with a secondary stimulus.

DETAILED DESCRIPTION

In the following detailed description, reference is made to theaccompanying drawings, which form a part hereof. In the drawings,similar symbols typically identify similar components, unless contextdictates otherwise. The illustrative embodiments described in thedetailed description, drawings, and claims are not meant to be limiting.Other embodiments may be utilized, and other changes may be made,without departing from the spirit or scope of the subject matterpresented here.

Various studies indicate that stimulation of the ear can have beneficialeffects on the health of a subject. For example, Rong et al.,“Transcutaneous vagus nerve stimulation for the treatment of depression:a study protocol for a double blinded randomized clinical trial,” BMCComplementary and Alternative Medicine 2012, 12:255, which isincorporated herein by reference, describes the possibility of usingtranscutaneous stimulation of the vagus nerve via portions of the ear totreat major depressive disorder (MDD) and other disorders, includingepilepsy, bipolar disorder, and morbid obesity. Enrich, “TranscutaneousVagus Nerve Stimulations,” European Neurological Review, 2011;6(4):254-256, which is incorporated herein by reference, describestranscutaneous vagus nerve stimulation via the ear for treating epilepsyand depression.

Nerves innervating the skin on or in the vicinity of the ear of thesubject include, e.g., the facial nerve (cranial nerve VII), theglossopharyngeal nerve (cranial nerve IX), the auricular branch of thevagus nerve (cranial nerve X), the auriculotemporal branch of trigeminalnerve (cranial nerve V), the lesser occipital nerve (spinal nerve C3),and the greater auricular nerve (spinal nerves C2, C3). These nervescontain various nerve fibers including sensory nerve fibers, including,for example, nerve fibers from skin mechanoreceptors. Various types ofskin mechanoreceptors are well characterized and are innervated byfibers having diameters in the range of approximately 5 to 12 μm (alsoknown as Aβ fibers). Skin mechanoreceptors include, for example, slowlyadapting mechanoreceptors, which are more sensitive to continuousstimulation, and rapidly adapting mechanoreceptors, which are moresensitive to transient stimuli. Rapidly adapting mechanoreceptorsinclude Pacinian corpuscles and Meissner's corpuscles, for example.

Mechanoreceptors are activated well by cyclical or vibratory (e.g.,sinusoidal) mechanical stimuli having frequencies in the range of 1 Hzto 1000 Hz. In some aspects, such mechanical stimuli may includeindentation of the skin by a few micrometers to a few millimeters.Pacinian corpuscles are thought to be most responsive to vibratorymechanical stimuli with frequencies in the range of 200 Hz-300 Hz, whileMeissner's Corpuscles are thought to be most responsive to vibratorymechanical stimuli with frequencies in the range of 30-40 Hz.

Electrical stimuli having sinusoidal or other waveforms are alsoeffective for activating sensory fibers. Stimuli may be appliedcyclically, for example. See e.g., Ellrich, “Transcutaneous Vagus NerveStimulations,” European Neurological Review, 2011; 6(4):254-256, whichis incorporated herein by reference.

For reference, FIG. 1 depicts an ear 100 of a human subject, showinganatomical structures which may be referred to herein. The externalportion of ear 100 is referred to as the pinna 102. FIG. 1 depicts afront/side view of ear 100, showing anterior surface of pinna 104, and aback view of ear 100, showing posterior surface of pinna 106 as well ashead 108 of the subject. The surface of the head 108 adjacent the pinna102 is indicated by shading and reference number 110. Anatomicalfeatures of the ear include external auditory meatus 112 (the externalear canal), helix 114, lobe 116, and tragus 118. Concha 120, theindented region in the vicinity of external auditory meatus 112, iscomprised of cymba 122 and cavum 124, and bounded by antitragus 126 andantihelix 128. Antihelix 128 includes inferior (anterior) crus ofantihelix 130 and superior (posterior) crus of antihelix 132, whichbound triangular fossa 134.

FIGS. 2A and 2B depict a generalized system 200 including a wearableneural stimulation device 202 for delivering a stimulus to an ear 204 ofa subject 206. System 200 includes a personal computing device 208 incommunication with wearable neural stimulation device 202 viacommunication link 210. Personal computing device 208 can be an audioplayer, a mobile phone, a computer, or any of various other deviceshaving computing capability (e.g., microprocessor based devices) andincluding application software and/or suitable hardware for controllingoperation of wearable neural stimulation device 202. In an aspect,personal computing device 208 is a wearable computing device. In anaspect, wearable neural stimulation device 202 is used to deliver astimulus sufficient to activate one or more nerves or nerve branchesinnervating the skin on or in the vicinity of ear 204 of subject 206. Inan aspect, personal computing device 208 is used to control delivery ofthe stimulus to ear 204 of subject 206. As illustrated in the blockdiagram of FIG. 2B, and described in greater detail herein below,wearable neural stimulation device 202 includes neural stimulator 212and securing member 214 for securing neural stimulator 212 to ear 204.In an aspect, personal computing device 208 is configured to send, orreceive, information relating to operation of the wearable neuralstimulation device 202 to, or from, one or more remote system 216 via acommunications network 218. Control of stimulation may be based on datafrom one or more sensor 220, including, but not limited to,physiological sensors, neural activity sensors, motion sensors, locationsensors, or environmental sensors, for example. In some aspects, sensor220 is worn by the subject at a location distinct from wearable neuralstimulation system 202 (e.g., on an armband as depicted in FIG. 2A). Inother aspects, one or more sensors are located on a wearable neuralstimulation device that can be implanted in the subject, located on thepersonal computing device, or located elsewhere in the environment ofthe subject, as depicted and described in the following text andaccompanying figures.

In the embodiment of FIGS. 2A and 2B, and in other embodiments describedherein, neural stimulator 212 can be any of various types of neuralstimulators, including but not limited to mechanical, electrical,magnetic, ultrasonic, optical, or chemical stimulators, as will bediscussed in greater detail herein below. In an aspect, neuralstimulation devices as described herein can include multiple (two ormore) neural stimulators (see e.g., optional additional neuralstimulator 222 in FIG. 2B). If multiple neural stimulators are used,they may all be of the same type, or may be of several different types.

In an aspect, neural stimulator 212 is a mechanical stimulator. In anaspect, a mechanical stimulator includes, for example, a vibratorymechanical stimulator that delivers a cyclical or vibrating mechanicalstimulus to the skin of the ear of the subject. Vibratory mechanicalstimulators can include, for example, various types of vibratingmechanical devices, e.g., electromechanical, piezoelectric, movablecoil, electrostatic, magnetostrictive, isodynamic, and/or MEMS devices,for example as used for manufacturing small-scale speakers andmicrophones.

In an aspect, neural stimulator 212 includes a transcutaneous electricalstimulator for delivering a transcutaneous electrical stimulus. Forexample, neural stimulator 212 may include an electrode or electricalcontact designed for contacting the skin surface, for example asdescribed in Rong et al., “Transcutaneous vagus nerve stimulation forthe treatment of depression: a study protocol for a double blindedrandomized clinical trial,” BMC Complementary and Alternative Medicine2012, 12:255, which is incorporated herein by reference. In an aspect,neural stimulator 212 includes a magnetic stimulator for delivering atranscutaneous magnetic stimulus. For example, such a magneticstimulator may include one or more coil through which electrical currentis passed to generate a magnetic field. The magnetic field induceselectrical currents within the tissue in/around the ear of the subjectto activate neural structures. In an aspect, neural stimulator 212includes an ultrasonic stimulator, for example as described in Legon etal., “Pulsed Ultrasound Differentially Stimulates Somatosensory Circuitsin Humans as Indicated by EEG and fMRI,” PLOS ONE 7(12): e5177.Doi:10.01371/journal.pone.0051177, December 2012, which is incorporatedherein by reference. In some aspects, other types of neural stimulators,such as optical or chemical stimulators are used. See, for example,stimulators described in U.S. Pat. No. 8,171,658 to Dacey, Jr. et al.,which is incorporated herein by reference.

In some aspects, circuitry for driving delivery of the neural stimulusis included fully or partially in wearable neural stimulation device202. In some aspects, some or all of the circuitry for driving deliveryof the neural stimulus are housed separately from wearable neuralstimulation device 202, and a control signal for driving delivery of theneural stimulus by neural stimulator 212 is provided by personalcomputing device 208, or from remote system 216 via communicationnetwork 218.

Various examples and embodiments of neural stimulation devices aredescribed herein. In various aspects of neural stimulation systemsdescribed herein, neural stimulation devices are wearable, i.e. thedevice can be carried by or worn on the ear of a subject, secured by asecuring member, in order to position one or more neural stimulator withrespect to a portion of the ear of the subject, or in some cases, in thevicinity of the ear of the subject. Various types of securing membersmay be used, without limitation. A securing member may also serve toposition one or more sensors on or in the vicinity of the ear of thesubject and may also include or support other system components, such aselectrical circuitry components. Examples of neural stimulation devicesincluding different types of securing members are shown in FIGS. 3-6.

FIG. 3 depicts securing member 300, which is a concha-fitted memberconfigured to fit into concha 302 of ear 304. In this example, securingmember 300 has a size and shape sufficient to be retained in concha 302by friction and/or tensioning of securing member 300 with respect toconcha 302. Other system components may be attached to securing member300, e.g., ear canal insert 306, which extends into external auditorymeatus (ear canal) 308 and stimulators 310 a, 310 b, and 310 c. Inaddition, system components may be built into or contained withinsecuring member 300, e.g., control and/or communication circuitry (notshown) used to drive stimulators 310 a, 310 b, and 310 c and/or providefor communication with e.g., a personal computing device (not shown). Abattery can be provided in securing member 300 to power the device forwireless operation. FIG. 3 also depicts a second type of securingmember, clip 312, for attaching stimulator 314 and/or sensor 316 to thepinna 318 of the subject. Circuitry 320 provides for wirelesscommunication between stimulator 314/sensor 316 and circuitry onsecuring member 300 or a personal computing device or remote system.Spring 322 provides spring force to secure clip 312 onto pinna 318. Clip312 may be formed of a resilient material or formed from two sections ofrigid material, joined at a hinge.

FIGS. 4A and 4B depict securing member 400 having a hanger-styleconfiguration designed to hang on pinna 402. The hanger-styleconfiguration is similar to the configuration used in certain types ofheadsets for listening to music. Securing member 400 includes anteriorportion 404, which in use (shown in FIG. 4B) is positioned anterior tothe ear of the subject (i.e. in front of pinna 402); over-ear portion406, which arcs over and behind pinna 402; and posterior portion 408,which fits behind pinna 402. In an aspect, securing member 400 includesdownward extension 410. In an aspect, wired communication link 412(e.g., a cable) provides for connection of electrical components onsecuring member 400 to a remote computing device. For example,electrodes 414 a and 414 b on posterior portion 408 of securing member400 are used to deliver electrical stimulation under control of acontrol signal delivered via wired communication link 412. Securingmember 400 also includes ear canal insert 416, which fits into theexternal auditory meatus 112. A sensor 418 on ear canal insert 416 canbe used to sense a physiological signal, which in some aspects is usedto determine the stimulation delivered with electrodes 414 a and 414 b.Physiological sensor 418 may include, for example, an electrode forsensing a heart rate, or other physiological sensor as described ingreater detail elsewhere herein. Additional sensors 420 and 422 arelocated on the aspect of posterior portion 408, facing and adapted tocontact the surface of the head adjacent the pinna 402. In an aspect,sensors 420 and 422 are electrodes configured to detect anelectroencephalographic (EEG) signal.

FIG. 5 depicts securing member 500 having a loop configuration of a typeused for wireless headsets. Securing member 500 includes earpieces 502 aand 502 b, which fit into the left and right ears of a subject,respectively (e.g., fitting into one or both of the concha and externalauditory meatus). Securing member 500 also includes arcs 504 a and 504b, which fit over and behind the two ears of the subject, and connectingloop 506 which fits behind the head of the subject and connectsearpieces 502 a and 502 b. In an aspect, securing member 500 issufficiently rigid to maintain earpieces 502 a and 502 b in position inthe ears of the subject while the subject moves about (e.g., walking orrunning). In an aspect, ear canal inserts 508 a and 508 b fit into theear canals of the subject. A neural stimulator 510 may be positioned onearpiece 502 a, as shown, or alternatively (or in addition) on ear canalextension 508 a. A secondary neural stimulator 512 may be located onpinna extension 514. Extension 514 serves to position secondary neuralstimulator 512 on the pinna of the subject at a desired location. In anaspect, extension 514 can be adjusted by elastic or plastic deformationto change the positioning of neural stimulator 512 on the pinna. In someaspects, extension 514 can include an adjustable linkage that providesfor positioning of neural stimulator 512 with respect to the pinna.

FIG. 5 depicts a system in which neural stimulators 510 and 512 arepositioned on securing member 500 so as to deliver stimulation to theleft ear of the subject. Depending upon the desired application, neuralstimulators can be positioned on one or both ears of the subject. Insome aspects, stimulation is delivered to only one ear, while in otheraspects, stimulation is delivered to both ears.

In some aspects, stimulator 512 located on pinna extension 514 can beused as the only, or primary neural stimulator, and stimulator 510 onearpiece 502 a can be omitted. Earpieces 502 a and 502 b can function tohold securing member 500 in place with respect to the head of thesubject, and, optionally, to deliver sound (such as a voice signal froma phone or music from an audio player) to the ears of the subject,independent of carrying stimulator 510. Circuitry 516 in securing member506 includes communication circuitry for wirelessly communicating withother system components, for example a personal computing device (e.g.,an audio player, a mobile phone, or a laptop computer). In addition,circuitry 516 may provide for wireless communication with a sensorlocated at a distance from securing member 500. For example, thewireless headset device depicted in FIG. 5 can be used in combinationwith sensors in one or more locations, not limited to sensors onsecuring member 500. Sensors include any type of physiological sensorlocated in, on or adjacent to the body of the subject (e.g., implantedsensors, sensors secured to the body, sensors in wearable items such asclothing, wristbands); remote sensors, environmental sensors, motionsensors, location sensors, and/or other types of sensors, withoutlimitation.

FIG. 6 depicts a further example of a wearable neural stimulation device600 including a housing 602 attached to a securing member 604. Housing602 is shown only in a dashed outline so that the position of stimulator606 and sensor 608 with respect to ear 610 can be seen. Housing 602 is athin, flat box-like structure, with stimulator 606 and sensor 608mounted on the exterior of housing 602 on the side facing pinna 612.Housing 602 is fastened to or formed integrally with securing member604. Securing member 604 fits into concha 614 to secure device 600 toear 610. Ear canal insert 616 fits into external auditory meatus 618.Sensor 620 on ear canal insert 616 senses a physiological signal fromexternal auditory meatus 618. Sensor 608 is an environmental sensor thatsenses light from the environment of the subject, e.g., to determinewhether it is day or night.

FIG. 7 is a block diagram of a neural stimulation system 700. Neuralstimulation 700 system includes neural signal sensor 702, which isadapted to sense a neural signal 704 from a subject. Neural signal 704may be an electroencephalographic (EEG) signal or electrooculographic(EOG) signal, and in an aspect is indicative of a physiological statusof the subject. Neural stimulation system 700 also includes neuralstimulator 706, which is adapted to produce a stimulus 708 responsive tosensed neural signal 704, stimulus 708 configured to activate at leastone sensory nerve fiber innervating at least a portion of a pinna of thesubject. Neural stimulation system 700 also includes securing member 710configured to secure neural stimulator 706 to the pinna of the subject.

In various aspects, neural signal sensor 702 can be anelectroencephalographic signal sensor 712 or electrooculographic signalsensor 714. Electroencephalographic signal sensor 712 can be configuredto fit within an ear canal of a subject, e.g., on an ear canal insert asdepicted in FIG. 4A (for example as described in U.S. Patent Publication2003/0195588 to Fischell et al., or U.S. Patent Publication 2006/0094974to Cain, both of which are incorporated herein by reference). EOG sensor714 can be located on an extension (e.g., similar to extension 514 shownin FIG. 5) to position EOG sensor 714 on the subject's temple or side ofthe subject's head. An electromyographic signal sensor could besimilarly placed. Physiological status of the subject, as indicated byneural signal 704, may include indications or symptoms of various typesof physiological status, including various brain-related disorders orstatuses, or other physiological statuses. Brain-related disordersinclude, for example, mental health disorders (e.g., psychological orpsychiatric disorder), depression, post-traumatic stress disorder,seasonal affective disorder, anxiety, headache (e.g., primary headache,cluster headache, or migraine headache), or epilepsy). Neural signalsensor 704 may include other types of neural signal sensors, includingexternal or implantable sensors, located in or on the ear or other partof the body. One or more neural signal sensors may be used.

In various aspects, securing member 710 is configured to secure neuralstimulator 706 to different portions of the pinna of the subject. Forexample, in an aspect, securing member 710 includes a concha-fittedportion 716, configured to fit into the concha of the subject (e.g., asdepicted in FIG. 3). In an aspect, securing member 710 includes an earcanal insert 718 configured to fit in the ear canal of the subject(e.g., as depicted in FIGS. 4A, 4B, and 5). In another aspect, securingmember 710 is a hanger-style securing member 720, as depicted in FIGS.4A and 4B. Hanger-style securing member 720 can be used to secure theneural stimulator to the back of the pinna, or to the surface of thehead adjacent the pinna. In another aspect, securing member 710 is aloop-style securing member 722, (e.g., of the type depicted in FIG. 5).In another aspect, securing member 710 includes a clip 724 (e.g., of thetype depicted in FIG. 3). A clip may be used to secure neural stimulator706 to various parts of the front or back of the pinna, including thefront or back of the ear lobe. In another aspect, securing member 720includes an extension 726 (e.g., such as extension 514 depicted in FIG.5). Such an extension can be used to position the neural stimulator invirtually any desired position on the pinna, or on the head adjacent toand above, below, in front of, or behind the ear. In an aspect, securingmember 710 includes a housing 728. It should be noted that housing 710may in some cases function as an extension. For example, housing 602depicted in FIG. 6 also functions as an extension extending fromsecuring member 604 to provide for placement and securing of stimulator606 and sensor 608 on a portion of the pinna 612 not immediatelyadjacent securing member 604. Securing member 710 can be configured tosecure the neural stimulator to the concha, tragus, front or back of thepinna, the helix, or various other parts of the pinna, e.g., thetriangular fossa, antihelix, superior or inferior crus of the antihelix,antitragus, or tragus of the subject. In some aspects securing member710 is permanently configured to position neural stimulator 706 in aparticular position with respect to the ear of the subject, wherein insome aspects securing member 710 is adjustable such that the positioningof neural stimulator 706 can be selected by the subject. For example, asensor or stimulator may be secured to a particular portion of the pinnaby being pressed sufficiently firmly against the pinna by the securingmember or extension to form a reliable mechanical or electrical contactwith the pinna. In an aspect, securing member 710 includes a shapememory material. Various materials may be suitable for the constructionof securing member 710, including but not limited to hard or soft,elastically or plastically deformable polymers, metals, ceramics,glasses, and composites formed therefrom. Flexible or stretchableelectronic circuitry, formed from flexible materials or structures (e.g.conductors having, e.g., a serpentine design) or resilient conductivematerials such as conductive polymers can be used in sensors andstimulators that conform to the pinna. While discussion herein hasfocused on positioning of the neural stimulator by securing member 710,it will be appreciated that securing member 710 can also be configuredto position sensors with respect to the ear in a similar fashion.Several such examples are provided in FIGS. 3-6.

In an aspect, the neural stimulator 706 is positioned with respect tosecuring member 710 such that when securing member 710 is worn on thepinna, neural stimulator 706 is positioned (secured) over a specificregion of the pinna, e.g., a region of the pinna innervated by a cranialnerve, e.g., the vagus nerve, the facial nerve, the trigeminal nerve, orthe glossopharyngeal nerve. Such positioning may be selected based uponknowledge of the innervation of the pinna, for example, as provided inreferences texts such as Cranial Nerves in Health and Disease, by LindaWilson-Pauwels, Elizabeth J. Akesson, Patricia A. Stewart, and Sian D.Spacey; BC Decker Inc.; 2 edition (Jan. 1, 2002); ISBN-10:1550091646/ISBN-13: 978-1550091649, which is incorporated herein byreference.

As noted above, neural stimulator 706 may be, for example, a mechanicalstimulator 730 (e.g., a vibratory mechanical stimulator 732), atranscutaneous electrical stimulator 734, a transcutaneous magneticstimulator 736, an ultrasonic stimulator 738, a chemical stimulator 740,a thermal stimulator 742, or other type of stimulator.

As shown in FIG. 7, in an aspect, neural stimulation system 700 includesat least one secondary sensor 750. In an aspect, neural signal sensor702 is a primary neural signal sensor, and secondary sensor 750 is asecondary neural signal sensor 752, which may be, for example, anelectroencephalographic (EEG) sensor 754, or electrooculographic (EOG)sensor 756. The secondary neural signal sensor 752 may be of the same ordifferent type as primary neural signal sensor 702, and may be locatedat the same or different location on the body as primary neural signalsensor 702. In an aspect, secondary sensor 750 is a physiological sensor758, for example, an electromyographic (EMG) sensor 755, a heart ratesensor 760 (which may be used to heart rhythm variability, as well asheart rate, and may include, but is not limited to, and EKG orpulse-oximeter based heart rate sensor), blood pressure sensor 762,perspiration sensor 764, skin conductivity sensor 766, respirationsensor 768, pupil dilation sensor 770, digestive tract activity sensor772, or piloerection sensor 774. In another aspect, secondary sensor 750is an environmental sensor, for example a light sensor 782, which may beconfigured to sense light level 784 and or day length 786. Environmentalsensor 750 may include a temperature sensor 788, or an acoustic sensor790, e.g., configured to sense ambient noise level 792. Other types ofsensors for providing information regarding the state of the subject andhis or her environment may be used, without limitation, including motionsensor 794 or location sensor 796, for example. A variety ofphysiological and environmental sensors are described in U.S. Pat. No.8,204,786 to LeBoueuf et al., which is incorporated herein by reference.Digestive tract activity may be sensed with external acoustical sensors,for example as described in “New disposable biosensor may helpphysicians determine which patients can safely be fed followingsurgery,” MedicalXpress, Aug. 7, 2014, which is incorporated herein byreference.

In an aspect, neural stimulation system 700 includes a secondary signalinput 800. In various aspects, the signal received at secondary signalinput 800 includes a signal from a delivery device 802 (indicative ofdelivery of a drug or nutraceutical to the subject), an input to a game804 (e.g., a signal corresponding to the subjects input to a video gameplayed by the subject), an output from a game 806 (e.g., a signal outputby a game system indicative of a state of or an event in a game playedby the subject), a user input to a virtual reality system 808, an outputfrom a virtual reality system 810 (e.g., a signal output by the VRsystem indicative of an state of or an event in the VR system), a userinput device 812 (e.g., a user input device of a computing device or auser input to the neural stimulation system), or a computing deviceinput 814 (e.g., a data input). Inputs received via a user input deviceor computing device input may be indicative of intake of a food item,beverage, nutraceutical, or pharmaceutical by the subject, for example.Inputs received via a user input device may be provided by the subject,or by another user, e.g. a medical caregiver. Inputs may be providedspontaneously by the user, or in response to a prompt or query. In anaspect, inputs may be provided by the user in response to queries orprompts that form a part of a quiz, questionnaire, or survey, including,e.g. questions presented in yes/no or multiple choice response format.User responses provided in response to such prompts or queries mayindicate the subject's mental or emotional state. Inputs received via adata input may include, for example, health-related information of thesubject, including genome information or microbiome information of thesubject, information from medical-records of the subject, or otherinformation pertaining to the health of the subject.

In an aspect, neural stimulation system 700 includes a clock or timer816. In various aspects, neural stimulator 706 is adapted to producestimulus 708 based at least in part on a time of day indicated byclock/timer 816, and/or based at least in part on a date indicated byclock/timer 816.

Data drawn from one or more neural signals, physiological signals,environmental signals, or other secondary signals (e.g. obtained withsecondary sensor 750 in FIG. 7) or secondary inputs (e.g. secondarysignal input 800 in FIG. 7), as well as clock or timer information, canbe correlated with a mental or emotional state of the subject, reportedto a medical care provider or other party, and/or stored in thesubject's medical or health records. In particular, values of any suchparameters that are indicative of worsening mental orphysical/physiological status of the subject can be reported to amedical care provider so that an appropriate intervention can be made,and/or used as a basis for modulating the delivery of neuralstimulation.

In various aspects, neural stimulation system 700 includes at least onesecondary stimulator 818 for delivery a secondary stimulus 820 to thesubject. In an aspect, secondary stimulator 818 is a secondary neuralstimulator 822, which may be any of the various types of neuralstimulators described in connection with neural stimulator 706, andwhich may be of the same or different type as neural stimulator 706.Alternatively, secondary stimulator 818 may include a mechanicalstimulator 824, an audio player 826, an auditory stimulus source 828, avirtual reality system 830, an augmented reality system 832, a visualstimulus source 834, a tactile stimulator 836, a haptic stimulator 838,an odorant source 840, a virtual therapist, or a delivery device 844,for delivering a drug or nutraceutical, for example.

In various aspects, neural stimulation system 700 includes controlcircuitry 846 carried by securing member 710 (either directly onsecuring member 710, or on an extension or housing connected to securingmember 710, e.g., as depicted in FIGS. 3-6), the control circuitry 846configured to control neural stimulator 706.

In an aspect, neural stimulation system 700 includes communicationcircuitry 848 carried by securing member 710 and configured for at leastone of sending one or more signal 850 to a personal computing device 852and receiving one or more signal 854 from personal computing device 852.

In an aspect, neural stimulation system 700 includes a sound source 856,for delivering an auditory signal to the subject. Sound source 856 maybe, for example, a speaker 858. Sound source 856 may be configured(e.g., with appropriate electronic circuitry, not shown) to delivery aninstruction 860 or alert 862 to the subject.

In an aspect, neural stimulation system 700 includes position sensor 864for sensing the position of neural stimulator 706 with respect to thepinna of the subject. Position sensor 864 may detect the position ofneural stimulator 706 with respect to the pinna by detecting electricalactivity from a nerve, by detecting an image of the ear and determiningthe position based on landmarks in the image, or by detecting atemperature, pressure, or capacitive signal indicative of adequatecontact of the stimulator with the ear, for example.

In an aspect, neural stimulation system 700 includes connector 866 forconnecting the neural stimulator to a personal computing device.Connector 866 includes, for example, a jack or port for creating a wired(cable) connection with the personal computing device. In an aspect,neural stimulation system 700 includes user interface 867 for receivinginput from the subject or presenting information to the subject. In anaspect, user interface 867 includes a small display, one or moreindicator lights and simple user inputs, such as one or more buttons ordials for adjusting device setting and viewing and modifying systemsettings.

FIG. 8 illustrates a generalized form of circuitry-based systems asdepicted in FIG. 7 and elsewhere herein. Although specific embodimentsare described herein, those skilled in the art will appreciate thatmethods and systems as described herein can be implemented in variousways. Reference is made herein to various circuitry systems andsubsystems (e.g., neural stimulation system 700 includescontrol/processing circuitry 846 in FIG. 7, which may be considered tobe control/processing circuitry. As shown generically in FIG. 8, asystem 870 includes a circuitry-based system 872. Circuitry-based system872, which in some aspects is a computing device or computing subsystem,includes control/processing circuitry 874, which includes any or all ofdigital and/or analog components 876, one or more processor 878 (e.g., amicroprocessor), and memory 880, which may store one or more programmodule 882 and/or data 884. In some aspects, control/processingcircuitry provides for preliminary handling of data from one or moresensor 886, transfer of data to remote device 896, receipt of controlsignal from remote device 896, and actuation of actuator 888, which maybe for example a neural stimulator (such as neural stimulator 706 asshown in FIG. 7). Systems as described herein may receive signals fromvarious sensors (e.g., sensor 886 depicted in FIG. 8). System 870 mayinclude other components as known to those skilled in the art, e.g., oneor more power supply 890, I/O structure 892, clock, timer, data bus,etc. I/O structure 892 permits communication with various types of userinterface devices (represented by user interface 894, which may includeone or more input devices such as a keyboard, button, switch, computermouse, or touchscreen or one or more output devices such as screen,sound source, alphanumeric display, Braille display, etc.) andcommunication with various types of remote device 896, e.g., remotesystem 216 in FIGS. 2A-2B, which may have control/processing capabilityconferred by control/processing circuitry 898.

In a general sense, the various embodiments described herein can beimplemented, individually and/or collectively, by various types ofelectrical circuitry having a wide range of electrical components suchas hardware, software, firmware, and/or virtually any combinationthereof. Electrical circuitry (including control/processing circuitry846 in FIG. 7, for example) includes electrical circuitry having atleast one discrete electrical circuit, electrical circuitry having atleast one integrated circuit, electrical circuitry having at least oneapplication specific integrated circuit, electrical circuitry forming acomputing device configured by a computer program (e.g., a computerconfigured by a computer program which at least partially carries outprocesses and/or devices described herein, or a microprocessorconfigured by a computer program which at least partially carries outprocesses and/or devices described herein), electrical circuitry forminga memory device, which may include various types of memory (e.g., randomaccess, flash, read only, etc.)), electrical circuitry forming acommunications device (e.g., communication circuitry 848 in FIG. 7)(e.g., a modem, communications switch, optical-electrical equipment,etc.), and/or any non-electrical analog thereto, such as optical orother analogs (e.g., graphene based circuitry). In an embodiment, thesystem is integrated in such a manner that the system operates as aunique system configured specifically for function of the neuralstimulation system described herein. In an embodiment, one or moreassociated computing devices of the system operate as specific usecomputers for purposes of the claimed system, and not general usecomputers. In an embodiment, one or more of the associated computingdevices of the system are hardwired with a specific ROM to instruct theone or more computing devices.

In a general sense, the various aspects described herein which can beimplemented, individually and/or collectively, by a wide range ofhardware, software, firmware, and/or any combination thereof can beviewed as being composed of various types of “electrical circuitry.”

At least a portion of the devices and/or processes described herein canbe integrated into a data processing system. A data processing systemgenerally includes one or more of a system unit housing, a videodisplay, memory such as volatile or non-volatile memory, processors suchas microprocessors or digital signal processors, computational entitiessuch as operating systems, drivers, graphical user interfaces, andapplications programs, one or more interaction devices (e.g., a touchpad, a touch screen, an antenna, etc.), and/or control systems includingfeedback loops and control motors (e.g., feedback for sensing positionand/or velocity; control motors for moving and/or adjusting componentsand/or quantities). A data processing system may be implementedutilizing suitable commercially available components, such as thosetypically found in data computing/communication and/or networkcomputing/communication systems.

In various embodiments, methods as described herein may be performedaccording to instructions implementable in hardware, software, and/orfirmware. Such instructions may be stored in non-transitorymachine-readable data storage media, for example. The state of the arthas progressed to the point where there is little distinction leftbetween hardware, software, and/or firmware implementations of aspectsof systems; the use of hardware, software, and/or firmware is generally(but not always, in that in certain contexts the choice between hardwareand software can become significant) a design choice representing costvs. efficiency tradeoffs. There are various vehicles by which processesand/or systems and/or other technologies described herein can beeffected (e.g., hardware, software, and/or firmware), and that thepreferred vehicle will vary with the context in which the processesand/or systems and/or other technologies are deployed. For example, ifan implementer determines that speed and accuracy are paramount, theimplementer may opt for a mainly hardware and/or firmware vehicle;alternatively, if flexibility is paramount, the implementer may opt fora mainly software implementation; or, yet again alternatively, theimplementer may opt for some combination of hardware, software, and/orfirmware in one or more machines, compositions of matter, and articlesof manufacture. Hence, there are several possible vehicles by which theprocesses and/or devices and/or other technologies described herein maybe effected, none of which is inherently superior to the other in thatany vehicle to be utilized is a choice dependent upon the context inwhich the vehicle will be deployed and the specific concerns (e.g.,speed, flexibility, or predictability) of the implementer, any of whichmay vary. Optical aspects of implementations will typically employoptically-oriented hardware, software, and or firmware.

In some implementations described herein, logic and similarimplementations may include software or other control structures.Electrical circuitry, for example, may have one or more paths ofelectrical current constructed and arranged to implement variousfunctions as described herein. In some implementations, one or moremedia may be configured to bear a device-detectable implementation whensuch media hold or transmit device detectable instructions operable toperform as described herein. In some variants, for example,implementations may include an update or modification of existingsoftware or firmware, or of gate arrays or programmable hardware, suchas by performing a reception of or a transmission of one or moreinstructions in relation to one or more operations described herein.Alternatively or additionally, in some variants, an implementation mayinclude special-purpose hardware, software, firmware components, and/orgeneral-purpose components executing or otherwise invokingspecial-purpose components.

Implementations may include executing a special-purpose instructionsequence or invoking circuitry for enabling, triggering, coordinating,requesting, or otherwise causing one or more occurrences of virtuallyany functional operations described herein. In some variants,operational or other logical descriptions herein may be expressed assource code and compiled or otherwise invoked as an executableinstruction sequence. In some contexts, for example, implementations maybe provided, in whole or in part, by source code, such as C++, or othercode sequences. In other implementations, source or other codeimplementation, using commercially available and/or techniques in theart, may be compiled/implemented/translated/converted into a high-leveldescriptor language (e.g., initially implementing described technologiesin C or C++ programming language and thereafter converting theprogramming language implementation into a logic-synthesizable languageimplementation, a hardware description language implementation, ahardware design simulation implementation, and/or other such similarmode(s) of expression). For example, some or all of a logical expression(e.g., computer programming language implementation) may be manifestedas a Verilog-type hardware description (e.g., via Hardware DescriptionLanguage (HDL) and/or Very High Speed Integrated Circuit HardwareDescriptor Language (VHDL)) or other circuitry model which may then beused to create a physical implementation having hardware (e.g., anApplication Specific Integrated Circuit).

This detailed description sets forth various embodiments of devicesand/or processes via the use of block diagrams, flowcharts, and/orexamples. Insofar as such block diagrams, flowcharts, and/or examplescontain one or more functions and/or operations, each function and/oroperation within such block diagrams, flowcharts, or examples can beimplemented, individually and/or collectively, by a wide range ofhardware, software, firmware, or virtually any combination thereof. Inan embodiment, several portions of the subject matter described hereinmay be implemented via Application Specific Integrated Circuits (ASICs),Field Programmable Gate Arrays (FPGAs), digital signal processors(DSPs), or other integrated formats. However, some aspects of theembodiments disclosed herein, in whole or in part, can be equivalentlyimplemented in integrated circuits, as one or more computer programsrunning on one or more computers (e.g., as one or more programs runningon one or more computer systems), as one or more programs running on oneor more processors (e.g., as one or more programs running on one or moremicroprocessors), as firmware, or as virtually any combination thereof,and that designing the circuitry and/or writing the code for thesoftware and or firmware would be well within the skill of one of skillin the art in light of this disclosure. In addition, the mechanisms ofthe subject matter described herein are capable of being distributed asa program product in a variety of forms, and that an illustrativeembodiment of the subject matter described herein applies regardless ofthe particular type of signal bearing medium used to actually carry outthe distribution. Examples of a signal bearing medium include, but arenot limited to non-transitory machine-readable data storage media suchas a recordable type medium such as a floppy disk, a hard disk drive, aCompact Disc (CD), a Digital Video Disk (DVD), a digital tape, acomputer memory, etc. A signal bearing medium may also includetransmission type medium such as a digital and/or an analogcommunication medium (e.g., a fiber optic cable, a waveguide, a wiredcommunications link, a wireless communication link (e.g., transmitter,receiver, transmission logic, reception logic, etc.) and so forth).

FIG. 9 is a flow diagram of a method 900 relating to use of a neuralstimulation system as depicted in FIG. 7. Here and elsewhere, methodsteps outlined with dashed lines represent steps that are included insome, but not all method aspects, and combinations of steps other thanthose specifically depicted in the figures are possible as would beknown by those having ordinary skill in the relevant art. Method 900includes sensing with a neural signal sensor a neural signal indicativeof a physiological status of a subject, the neural signal sensor locatedin or on a portion of a body of the subject, as indicated at 902;determining with signal analysis circuitry at least one parameter of thesensed neural signal, as indicated at 904; and delivering a neuralstimulus with a neural stimulation device worn on a pinna of the subjectresponsive to the sensed neural signal, wherein the neural stimulus isconfigured to modulate the activity of at least one sensory nerve fiberinnervating at least a portion of the pinna of the subject, as indicatedat 906. In an aspect, the neural stimulus is of sufficient frequency andamplitude to modulate the activity of the at least one sensory nervefiber innervating the at least a portion of the pinna of the subject.For example, in various aspects the neural stimulus has a frequency inthe approximate range of 1 Hz-1000 Hz, 10 Hz-500 Hz, 30 Hz-40 Hz, 10Hz-50 Hz, 10 Hz-80 Hz, 50 Hz-100 Hz, or 200-300 Hz. In an aspect, thestimulus has a sinusoidal waveform. In other aspects, the stimulus mayhave a triangular, rectangular, square, trapezoidal, or other waveform,delivered cyclically, with cycle frequencies in the ranges listed above.It will be appreciated that depending on the stimulus waveform or pulseshape, or envelope shape, a given stimulus may include higher or lowerfrequencies. The neural stimulus may be delivered according toprogrammed pattern, which may be stored in memory on the neuralstimulation device or on a personal computing device or other remotedevice in communication with the neural stimulation device. In variousaspects, the neural stimulus is delivered continuously, intermittently,and/or in a time-varying fashion. The neural stimulus may be a pulsedstimulus.

In an aspect, the neural stimulus is delivered with a neural stimulationdevice and/or neural stimulus configured to activate a cranial nerve,such as the vagus nerve, facial nerve, trigeminal nerve, orglossopharyngeal nerve. The neural stimulation device can be configuredto stimulate a particular nerve by one or both of positioning the neuralstimulator on at least a portion of a receptive field of the nerve ofinterest, and selecting the amplitude and other stimulus parameters(e.g. frequency, waveform, duration) of the stimulus delivered toactivate the nerve fibers in the nerve of interest.

In an aspect, the method includes delivering the neural stimulusresponsive to the at least one parameter of the sensed neural signal.The at least one parameter may include, for example, a frequency contentof an electroencephalographic signal, an amplitude of anelectroencephalographic signal, a rate of eye movement determined froman electrooculogram, or a gaze direction determined from anelectrooculogram. In some aspects, such parameters are indicative of abrain-related disorder, or symptoms thereof. In an aspect, method 900includes delivering the neural stimulus in response to detection ofsymptoms of a brain-related disorder (which may be, for example, anymental health disorder (e.g., psychological or psychiatric disorder),depression, post-traumatic stress disorder, seasonal affective disorder,anxiety, headache (e.g., primary headache, cluster headache, or migraineheadache), or epilepsy). In an aspect, the method includes deliveringthe neural stimulus until symptoms of the brain-related disorder are nolonger detected.

In an aspect, method 900 includes sensing at least one secondary signalwith a secondary sensor. In an aspect, delivery of the neural stimulusmay be started, stopped, or modulated in response to the secondarysignal. The secondary signal may be a secondary neural signal (of thesame or different type and sensed from the same or from a differentlocation than the primary neural signal), or it may another type ofphysiological signal, an environmental signal, a location signal, or asignal from a motion sensor, for example. Such secondary signals mayprovide additional information relevant for determining whether theneural stimulus should be applied, assessing the subject's response tothe neural stimulus, identifying appropriate time of delivery of theneural stimulus, etc. The secondary signal may include other types ofsecondary signal, e.g., as received by secondary signal input 800 inFIG. 7. In an aspect, method 900 includes delivering at least onesecondary stimulus to the subject in addition to the neural stimulusdelivered with the neural stimulation device. The secondary stimulus maybe any of various types of secondary stimulus, e.g., as delivered withsecondary stimulator 818 as described in FIG. 7. In various aspects,method 900 includes controlling the neural stimulation device withcontrol circuitry located at least in part on the neural stimulationdevice, or with control circuitry located at least in part on a personalcomputing device in communication with the neural stimulation deviceworn on the pinna of the subject. In an aspect, method 900 includessending a signal from the neural stimulation device worn on the pinna ofthe subject to a personal computing device or receiving a signal from apersonal computing device at the neural stimulation device worn on thepinna of the subject. In an aspect, method 900 includes delivering anauditory instruction or an auditory alert to the subject with a soundsource operatively connected to the neural stimulation device. In anaspect, method 900 includes sensing a position of the neural stimulationdevice relative to the pinna of subject with a position sensoroperatively connected to the neural stimulation device. If the neuralstimulation device is not positioned properly positioned, the auditoryinstruction or alert may remind the subject to correct the positioningof the neural stimulation device. Alternatively, or in addition, visualalerts can be provided to the subject, in the form of one or moreblinking light, graphic, or a text message, delivered via an LED orother light emitting element, an alphanumeric display, a screen, orother display element on the neural stimulation device or on thepersonal computing device.

FIG. 10 depicts an embodiment of a wearable neural stimulation device1000 that includes a vibratory mechanical stimulator 1002. Vibratorymechanical stimulator 1002 is adapted to produce a vibratory stimulus ofsufficient frequency and amplitude to modulate the activity of at leastone mechanoreceptor with a receptive field on at least a portion of apinna of a subject, and a securing member 710 configured to securevibratory mechanical stimulator 1000 to the pinna. Securing member 710is as described herein above. Vibratory mechanical stimulator 1002 is avibratory stimulator, such as vibratory stimulator 732 describedgenerally in connection with FIG. 7. In various aspects, vibratorymechanical stimulator 1002 includes an electromechanical device 1004,piezoelectric device 1006, movable coil 1008, electrostatic device 1010,magnetostrictive device 1012, isodynamic device 1014, a MEMS device1016, and/or a stretchable electronic device 1018.

In an aspect, neural stimulation device 1000 includes at least onesensor 1020, which may be any of the various types of sensors describedin connection with secondary sensor 750 in FIG. 7, e.g., a physiologicalsensor 758, a neural signal sensor 752, an environmental sensor 780, amotion sensor 794 or a location sensor 796. In various aspects, neuralstimulation device 1000 includes a secondary signal input 800, secondarystimulator 818, control circuitry 846 carried by securing member 710,communication circuitry 848, sound source 856, position sensor 864, andconnector 866, all of which have been discussed in connection with FIG.7.

FIG. 11 is a flow diagram of a method 1100 relating to use of a neuralstimulation system as depicted in FIG. 10. In an aspect, method 1100includes delivering a vibratory mechanical stimulus to at least aportion of a pinna of a subject with a neural stimulation device worn onthe pinna of the subject, wherein the vibratory mechanical stimulus isof sufficient frequency and amplitude to modulate the activity of atleast one mechanoreceptor with a receptive field on the at least aportion of the pinna, as indicated at 1102. In an aspect, method 1100includes delivering the vibratory mechanical stimulus over a spatialextent of the pinna sufficient to modulate the activity of the at leastone mechanoreceptor, as indicated at 1104.

In an aspect, the vibratory mechanical stimulus has a waveformsufficient to modulate the activity of the at least one mechanoreceptorwith a receptive field on the at least a portion of the pinna. Forexample, the vibratory mechanical stimulus may have a sinusoidal orother waveform. In some aspects, the vibratory mechanical stimulus isdelivered according to programmed pattern, which may include deliveringthe vibratory mechanical stimulus either continuously or intermittently.

In an aspect, as indicated at 1106, method 1100 includes sensing asignal with a sensor and controlling the delivery of the vibratorymechanical stimulus based at least in part on the sensed signal. Thesensed signal may be any of the various types of signal sensed withsensor 1018 in FIG. 10. In various aspects, controlling delivery of thevibratory mechanical stimulus based at least in part on the sensedsignal includes modulating delivery of the neural stimulus in responseto the sensed signal, or delivering the vibratory mechanical stimulus inresponse to the sensed signal. In an aspect, controlling the delivery ofthe vibratory mechanical stimulus based at least in part on the sensedsignal includes initiating delivery of the vibratory mechanical stimulusin response to the sensed signal.

In an aspect, method 1100 includes receiving a signal from an input andcontrolling the delivery of the vibratory mechanical stimulus based atleast in part on the received signal, as indicated at 1108. The receivedsignal may be e.g., any of the various types of input signals receivedat secondary signal input 800 in FIG. 10.

In an aspect, method 1100 includes sensing at least one second sensedsignal with a second sensor and controlling the delivery of thevibratory mechanical stimulus based at least in part on the secondsensed signal, as indicated at 1110.

In an aspect, method 1100 also includes delivering a secondary stimulusto the subject, as indicated at 1112, which may include delivering asecondary stimulus with a secondary stimulator 818, as described inconnection with FIG. 7.

As discussed in connection with method 900, the vibratory mechanicalstimulus can be delivered in response to detection of symptoms of abrain-related disorder, which may include, for example, a mental healthdisorder, depression, post-traumatic stress disorder, seasonal affectivedisorder, anxiety, headache, or epilepsy. In an aspect, method 1100includes delivering the vibratory mechanical stimulus until symptoms ofthe brain-related disorder are no longer detected.

FIG. 12 depicts a neural stimulation system 1200 which includes awearable neural stimulation device 1202 and personal computing device1204. Personal computing device 1204 may be packaged separately fromwearable neural stimulation device 1202, e.g., similar to the systemdepicted in FIGS. 2A and 2B. Wearable neural stimulation device 1202includes neural stimulator 706, which is adapted to produce a stimulusfor activating at least one sensory nerve fiber innervating at least aportion of a pinna of a subject, securing member 710 configured tosecure the neural stimulator to the pinna, control circuitry 1206 forcontrolling operation of neural stimulator 706, and first communicationcircuitry 1208. Neural stimulator 706 and securing member 710 are asdescribed herein above in connection with FIG. 7. Both control circuitry1206 and first communication circuitry 1208 are incorporated into thewearable neural stimulation device 1202. First communication circuitry1208 is operatively connected to control circuitry 1206 and isconfigured for at least one of sending a signal 1210 to and receiving asignal 1212 from personal computing device 1204. Other system componentsthat may be included in or used in connection with wearable neuralstimulation device 1202 include secondary signal input 800, secondarystimulator 818, sound source 856, position sensor 864 and connector 866,as described herein above in connection with FIG. 7, and sensor 1018 asdescribed herein above in connection with FIG. 10. In an aspect, neuralstimulation system 1200 includes user interface 1221, including userinput device 1222 which is used to receive an input from the subject orother user, and user output device 1223. User input device 1222 may beany of various types of user input devices known to those of ordinaryskill in the art, including but not limited to a button, keyboard,keypad, touchscreen, voice input, etc. In system 1200 and in otherneural stimulation systems described herein, system components such assecondary signal input 800, secondary stimulator 818, sound source 856,position sensor 864, connector 866, sensor 1018, and user input device1221 may in some cases be built into the wearable neural stimulationdevice (e.g., wearable neural stimulation device 1202) and in some casesbe packaged separately but used in combination with the wearable neuralstimulation device. For example, sensors may be located on the subject'sbody at a location other than the ear, or in the vicinity of the subjectbut not on the subject's body. In some cases, sensors may be implantedwithin the subject's body. Similarly, one or both of a secondarystimulator and a sound source can be located on the wearable neuralstimulation device, on the subject's body distinct from the neuralstimulation device, or in the vicinity of the subject but not on thesubject's body.

Personal computing device 1202 includes a user interface 1214 for atleast one of presenting information to and receiving information from auser, control circuitry 1216 operatively connected to user interface1214, and second communication circuitry 1218 configured for at leastone of sending a signal to and receiving a signal from the firstcommunication circuitry 1208 carried by the housing of the wearableneural stimulation device. In addition, personal computing device 1202includes instructions 1220 that when executed on personal computingdevice 1204 cause personal computing device 1204 to perform at least oneof sending signal 1212 to and receiving signal 1210 from wearable neuralstimulation device 1202 via second communication circuitry 1218.

Communication circuitry 1208 and communication circuitry 1218 providefor communication between wearable neural stimulation device 1202 andpersonal computing device 1204. In addition, in some aspects one or bothof communication circuitry 1208 and communication circuitry 1218 providefor communication of wearable neural stimulation device 1202 or personalcomputing device 1204, respectively, with a remote system 1224. In someaspects, communication circuitry 1208 and communication circuitry 1218provide for wired communication between wearable neural stimulationdevice and personal computing device 1204. Wired communication towearable neural stimulation device may occur via connector 866.Alternatively, or in addition, a wireless communication link may beestablished between wearable neural stimulation device 1202 and personalcomputing device 1204, and/or between either wearable neural stimulationdevice 1202 or personal computing device 1204 and remote system 1224. Invarious aspects, a wireless communication link includes at least one ofa radio frequency, wireless network, cellular network, satellite, WiFi,BlueTooth, Wide Area Network, Local Area Network, or Body Area Networkcommunication link. Various types of communication links are suitablefor providing communication between two remote locations. Communicationbetween locations remote from each other may take place overtelecommunications networks, for example public or private Wide AreaNetwork (WAN). In general, communication between remote locations is notconsidered to be suitably handled by technologies geared towardsphysically localized networks, e.g., Local Area Network (LAN)technologies operation at Layer 1/2 (such as the forms of Ethernet orWiFi). However, it will be appreciated that portions (but not theentirety) of communication networks used in remote communications mayinclude technologies suitable for use in physically localized network,such as Ethernet or WiFi.

In an aspect, personal computing device 1204 is personal digitalassistant 1226, a personal entertainment device 1228, a mobile phone1230, a laptop computer 1232, a tablet personal computer 1234, awearable computing device 1236 (e.g., a fitness band, an item ofclothing, attire, or eyewear incorporating computing capability), anetworked computer 1238, a computing system comprised of a cluster ofprocessors 1240, a computing system comprised of a cluster of servers1242, a workstation computer 1244, and/or a desktop computer 1246. Invarious aspects, personal computing device 1204 includes one or more ofa portable computing device, a wearable computing device, a mobilecomputing device, and a thin client computing device, for example.

FIG. 13 depicts aspects of a system 1300 including personal computingdevice 1302, for use in connection with neural stimulation system 1303,which is a neural stimulation system such as described herein above.Personal computing device 1302 is as described generally in connectionwith FIG. 12. In an aspect, personal computing device 1302 includescircuitry 1304 for receiving a neural activity signal 1306, circuitry1308 for determining a neural stimulus control signal 1310 based atleast in part on neural activity signal 1306, and circuitry 1312 foroutputting neural stimulus control signal 1310 to neural stimulationdevice 1314. In an aspect, neural activity signal 1306 is sensed byneural signal sensor 1315, and is indicative of a physiological statusof a subject. Neural activity signal 1306 may be an unprocessed neuralsignal, or neural activity signal 1306 may have been subjected tovarious types and amounts of signal processing, and/or analysis(including, but not limited to filtering, amplification, analog todigital conversion, signal averaging, conversion from time to frequencydomain, feature extraction, and so forth). Neural activity signal 1306may include neural activity sensed from one or more neural signalsensors 1315 (which may be electroencephalographic sensors orelectrooculographic sensors, for example). Neural activity signal 1306may include information derived from or associated with the sensedneural signal, and may include or be accompanied by additionalinformation that identifies the type of signal, type of processing towhich the signal has been subject, data formatting, device settings usedduring acquisition of the neural signal, etc. Neural signal sensor 1315is a component of neural stimulation system 1303, and may be a componentof neural stimulation device 1314, or used in association therewith, asdescribed herein above. Neural stimulation device 1314 includes externalneural stimulator 1316, which is configured to be carried on a pinna ofthe subject. Neural stimulus control signal 1310 is configured tocontrol delivery of a neural stimulus by external neural stimulator1316, the neural stimulus configured to activate at least one sensorynerve fiber innervating at least a portion of the pinna.

Neural activity signal input 1304 (the circuitry for receiving neuralactivity signal 1306) includes, for example, a headphone jack 1318, datainput 1320, wireless receiver 1322, or network connection 1324. Invarious aspects neural activity signal input 1304 includes circuitry forreceiving a signal from a body area network, a local area network, or awide area network.

Neural stimulus control signal determination circuitry 1308 includes oneor more of amplitude determination circuitry 1326 for determining aneural stimulus amplitude, frequency determination circuitry 1328 fordetermining a neural stimulus frequency, waveform determinationcircuitry 1330 for determining a neural stimulus waveform, patterndetermination circuitry 1332 for determining a neural stimulus pattern,or duration determination circuitry 1333 for determining a neuralstimulus duration. In an aspect, personal computing device 1302 includesdata storage circuitry 1334 for storing data on the data storage device,including memory 1336 and circuitry for accessing data stored therein.Memory 1336 may contain stored preprogrammed stimulus patterns andwaveforms as well as neural stimulus parameter values from which neuralstimuli can be computed. In an aspect, system 1300 includes data storagecircuitry 1334 for storing data on personal computing device 1302representing neural stimulus control signal 1338. In an aspect, system1300 includes data storage circuitry 1334 for storing data on personalcomputing device 1302 representing previous neural activity 1340. In anaspect, neural activity prediction circuitry 1342 predicts a futureneural activity signal based on a previous neural activity signal.

In an aspect, system 1300 includes secondary stimulus determinationcircuitry 1344 for determining a secondary stimulus based on neuralactivity signal 1306. In an aspect, secondary stimulus determinationcircuitry 1344 determines the secondary stimulus control signal 1346based on previous neural activity signal 1340.

In an aspect, system 1300 includes reporting circuitry 1348 forproviding a report 1350 to at least one recipient. Reporting circuitry1348 may cause report 1350 to be provided via a user interface 1214 (asdescribed in connection with FIG. 12) or via a computing network(accessed via communication circuitry 1218). In an aspect, report 1350is provided to the subject using the neural stimulation device 1314. Inanother aspect, report 1350 is provided to other parties, for example, amedical care provider, an insurance company, a service provider (e.g., abusiness or other entity that provides services related to the neuralstimulation device or related to monitoring use of the neuralstimulation device). In an aspect, report 1350 is provided to at leastone social media contact (or ‘friend’), or to a peer of the subject,e.g., via a social network. In an aspect, the recipient is a computingsystem, e.g. a computing system used for storing and/or processinghealthcare information. In various aspects, anonymization circuitry 1352is used to provide the report in anonymized form (e.g., with informationidentifying the subject removed therefrom). Reporting circuitry 1326 mayinclude circuitry for including various information in report 1350,e.g., information relating to one or more of neural activity signal 1306or information derived therefrom, neural stimulus control signal 1310,settings for neural stimulation device 1314 or personal computing device1302, stored neural activity data 1340, secondary input signal 1354, andsecondary stimulus control signal 1346. In an aspect, system 1300includes secondary stimulus control signal output circuitry 1356 fordelivering secondary stimulus control signal 1346 to secondarystimulator 1358. Secondary stimulator 1358 can be any type ofstimulator, for example such as secondary stimulator 818 described inconnection with FIG. 7.

In an aspect, system 1300 includes secondary signal input 1360 forreceiving a secondary input signal 1354 at personal computing device1302. In an aspect, neural stimulus control signal determinationcircuitry is configured to determine neural stimulus control signal 1310based at least in part on secondary input signal 1354. Secondary inputsignal may be representative of a physiological parameter of the subjector an environmental parameter of the subject, and may include a signalsensed from a sensor on or associate with neural stimulation device1314, or a sensor in the environment of the subject, and/or parametersor values derived from such sensed signals. In an aspect, the secondaryinput signal is indicative of a user input provided by the subject. Inan aspect, secondary input signal 1354 may be received via user input1362 in user interface 1214.

In an aspect, system 1300 includes circuitry for presenting arecommendation to the subject. The recommendation may be presented tothe subject via user output 1364 of user interface 1214, e.g., via audiooutput 1366 and/or graphical display 1368 or transmitted to neuralstimulation device 1303 and presented via a user interface on neuralstimulation device 1303. In an aspect, system 1300 includesrecommendation receiving circuitry 1370 for receiving recommendation1372 at personal computing device 1302. For example, in an aspectrecommendation receiving circuitry 1370 receives recommendation 1372 viaa computing network. In various aspects, recommendation 1372 is receivedfrom a medical care provider, from an insurance company, a serviceprovider, an advisor, a computation-based system (including, e.g. anartificial intelligence), or a social media source, for example. Invarious aspects, recommendation receiving circuitry 1370 is configuredto receive recommendations from particular sources, e.g. by receivingalong with the recommendation a code indicating the source of therecommendation (e.g., a specific medical care provider, a medical careprovider as opposed to a social media source), and to recognize a sourceof the recommendation and respond differently depending upon the sourceof the recommendation. Recommendation receiving circuitry 1370 may beconfigured such that recommendations from more credible sources maypresented to the subject more promptly or more prominently, whereasrecommendations from undesirable sources may be blocked, for example.Recommendation 1372 may relate to a configuration of neural stimuluscontrol signal 1319 or secondary stimulus control signal 1346. In otheraspects, recommendation 1372 relates to one or more of a consumerproduct, a service, a user experience, a user activity, or anorganization that may be of interest to the subject, e.g., because therecommendations would enhance or be compatible with the effects of theneural stimulation received by the subject, or in some other mannerrelate to the neural stimulation or the condition which it is intendedto treat. For example, the recommendation might be for software forstoring, presenting, sharing, or reporting stimulation data or healthdata or for an organization that provides counseling to individuals witha particular condition. In an aspect, user input 1362 is configured toreceive acceptance/rejection signal 1374 from the subject regardingacceptance or rejection of recommendation 1372.

In an aspect, system 1300 includes patch or update receiving circuitry1376 for receiving patch/update 1378 at personal computing device 1302.Patch/update 1378 includes a software patch or update for softwareresiding on personal computing device 1302 or neural stimulation device1314 and may be received, for example, from the manufacturer of neuralstimulation device 1314, from a service provider, or the like. In anaspect, personal computing device 1302 includes update circuitry 1380for applying the patch or update to software installed on personalcomputing device 1302 or to software installed on neural stimulationdevice 1314, by sending update signal 1382 to neural stimulation system1303. In an aspect, update circuitry 1380 also provides for updating aconfiguration of at least one of the neural stimulation device and thepersonal computing device, the configuration relating to operation ofthe neural stimulation device. In an aspect, update circuitry 1380 canbe configured to update the configuration of at least one of the neuralstimulation device and the personal computing device based on historicaldata (e.g., as stored in memory 1336). In another aspect, updatecircuitry 1380 is configured to update the configuration based on atleast one instruction 1384. In an aspect, instruction 1384 is receivedvia user input 1362 of personal computing device 1302. In anotheraspect, instruction 1384 is received from a computing network, (e.g.,from a remote device or system, via a data input such as I/O 892depicted in FIG. 8). In various aspects, instruction 1384 is receivedfrom a medical care provider, an insurance company, or a serviceprovider, for example.

In another aspect, update circuitry 1380 is configured to update theconfiguration of at least one of the neural stimulation device and thepersonal computing device based on at least one recommendation 1372. Asdiscussed herein above, recommendation 1372 is received byrecommendation receiving circuitry 1370, and can be received from anadvisor, from a computation-based system (e.g., an artificialintelligence, machine learning system, or search engine based on adata-driven technique), or from a social media source (for example, invarious aspects, the recommendation is based on the at least onepreference of at least one social media contact, peer, or role model ofthe subject). In addition, acceptance/rejection input 1374 is receivedfrom the subject by user interface 1214 regarding acceptance orrejection of the recommendation, and update circuitry 1380 updates theconfiguration responsive to acceptance of the recommendation by thesubject (if the recommendation is rejected, no update is made inresponse to the recommendation). As an alternative, acceptance orrejection of the recommendation can be provided by a caregiver of thesubject regarding received via either user interface 1214 or via a datainput from a remote device or system. Update circuitry 1380 updates theconfiguration responsive to acceptance of the recommendation by thecaregiver of the subject. In another aspect, update circuitry 1380 isconfigured to update the configuration of at least one of the neuralstimulation device and the personal computing device based on anenvironmental parameter (based in a secondary input signal 1354 receivedat secondary signal input 1360. In another aspect, update circuitry 1380is configured to update the configuration of at least one of the neuralstimulation device and the personal computing device automatically. Forexample, in an aspect, the configuration is updated automaticallyaccording to a schedule, for example when the time and/or date indicatedby clock/timer 1386 matches an update time/date in schedule 1388 storedin memory 1336.

In an aspect, neural activity signal input 1304 includes circuitry forreceiving neural activity signal 1306 via a secure connection. In anaspect, neural control signal output 1312 includes circuitry foroutputting neural stimulus control signal 1346 via a secure connection.The secure connection may include be provided through the use of anencrypted signal, for example.

In an aspect, system 1300 includes output circuitry 1390 for presentinginformation to the subject via user interface 1214, including e.g.,audio output 1366, graphical display 1368, alphanumeric display 1392,touchscreen 1394, or other user interface devices, as known to those ofordinary skill in the art.

In an aspect, system 1300 includes customization circuitry 1396.Customization circuitry 1396 customizes for the subject one or both ofthe information, or the formatting of the information, that is presentedto via user interface 1214, based on user preferences, for example.

In an aspect, system 1300 includes authentication circuitry 1398 forreceiving a credential 1400 showing that the subject is an authorizeduser. In an aspect, output circuitry 1390 presents information to thesubject via user interface 1214 only following receipt of credential1400 showing that the subject is an authorized user. In various aspects,authentication circuitry 1398 receives a password, a personalidentification number, a biometric feature, or a card authentication,for example.

In an aspect, output circuitry 1390 includes output format circuitry1402 for presenting the information to the subject via user interface1214 in a graphical format that mimics the graphical format of an audioplayer, in a graphical format that mimics the graphical format of amobile phone, or in any other graphical format that mimics the graphicalformat of a familiar user interface. This permits the subject to use theneural stimulation device discretely, and present to observers theimpression that the personal computing device is functioning as a mobilephone or audio player rather than being used in connection with a neuralstimulation device. In an aspect, output circuitry 1390 changes ordiscontinues the presenting of information to the subject via the userinterface in response to an input signal 1404. For example, outputcircuitry 1390 switches between a first graphical format and a secondgraphical format on user interface 1214 in response to input signal1404. For example, the first graphical format may present informationrelating to the neural stimulus, while the second graphical format maymimic the format of a mobile phone or audio player. In an aspect, inputsignal 1404 is a user input signal, received for example via userinterface 1214. In another aspect, input signal 1404 is a sensedenvironmental signal indicative of presence of another person (e.g., anaudio input signal containing the detected voice of the other person,received via secondary input signal 1354). In an aspect, input signal1404 is indicative of a time (e.g., a signal received from clock/timer1386 on personal computing device 1302).

In an aspect, neural stimulus control signal determination circuitry1308 modulates neural stimulus control signal 1310 in response to anoverride signal. For example, in an aspect override signal is inputsignal 1404 received via user input 1362. In an aspect, override signalis secondary input signal 1354, received via secondary signal input1360. In an aspect, the override signal originates from a sensor thatsenses a physiological parameter, such as heart rate. In the event thatthe physiological parameter indicates an unsafe condition (e.g., theheart rate is too high or too low), the neural stimulus control signaldetermination circuitry 1308 modulates neural stimulus control signal1310 to discontinue production of the neural stimulus. For example, invarious aspects, the override signal originates from a sensor responsiveto sensing a presence of a person other than the subject in the vicinityof the subject or responsive to sensing that the external neuralstimulator is not properly positioned on the pinna of the subject. In anaspect, neural stimulus control signal determination circuitry 1308modulates neural stimulus control signal 1310 to discontinue productionof the neural stimulus. In an aspect, neural stimulus control signaldetermination circuitry 1308 modulates neural stimulus control signal1310 to change an intensity of the neural stimulus. In addition tomodulating or discontinuing the neural stimulus in response to anoverride condition (e.g., physiological parameter indicative of anunsafe condition, improper positioning of the external neuralstimulator, etc.), a notification may be sent to the subject and/or to amedical care provider or other party regarding the override condition,to prompt the recipient of the notification to take corrective action,or for inclusion of the information in the subject's medical records.

In an aspect, secondary signal input 1360 is adapted to receive aposition signal indicative of a position of the external neuralstimulator with respect to the pinna of the subject. In connectiontherewith, system 1300 may also include notification circuitry 1406 fordelivering a notification to the subject indicating that the externalneural stimulator should be repositioned. In an aspect, notificationcircuitry 1406 includes circuitry for delivering the notification via agraphical display 1368 of personal computing device 1302. In an aspect,notification circuitry 1406 includes circuitry for delivering anauditory alert, either via audio output 1366 of personal computingdevice, or by generating an appropriate audio output signal 1408 fordriving production of the auditory alert by a sound source 1410 onneural stimulation device 1314. In an aspect, notification circuitry1406 includes circuitry for delivering a voice message (e.g., a presetmessage retrieved from memory 1336). In a further aspect, notificationcircuitry 1406 includes circuitry for storing information indicatingthat stimulator 1316 is improperly positioned in a data storage location(e.g., memory 1336) in personal computing device 1302. In anotheraspect, notification circuitry 1406 provides for storing informationindicating that stimulator 1316 is improperly positioned in a datastorage location in neural stimulation device 1314 (e.g., bytransmitting such information to neural stimulation device 1314.

In an aspect, system 1300 includes circuitry for outputting an audiooutput signal, either via an audio output 1366 of personal computingdevice 1302 or via sound source 1410 of neural stimulation device 1314,where the audio output signal drives delivery of sound to the ear of thesubject via a sound source. In an aspect, output circuitry 1390 is usedto output the audio output signal via audio output 1366 of the personalcomputing device. In an aspect, communication circuitry 1218 is used fortransmitting audio output signal 1408 to a sound source 1410 on neuralstimulation device 1314. Alternatively, communication circuitry 1218 canbe used to deliver an audio output signal to sound source distinct fromthe neural stimulation device (e.g., a sound source included in a deviceused by the subject, but not included in the neural stimulation device).In an aspect, output circuitry 1390 retrieves an audio signal from adata storage location (e.g., memory 1336) on personal computing device1302, and generate audio output signal based on the retrieved audiosignal. In another aspect, system 1300 includes audio receiver 1412 forreceiving audio input signal 1414 from a telecommunication network. Forexample, in various aspects, audio input signal 1414 is a broadcastradio signal, a webcast audio signal, or a mobile phone signal.

In an aspect, system 1300 includes prioritization circuitry 1416 forprioritizing delivery of the neural stimulus control signal relative tothe audio output signal (either audio output signal 1408 for delivery tosound source 1410, and/or an audio output signal delivered via audiooutput 1366 on personal computing device 1302). In an aspect,prioritization circuitry 1416 automatically discontinues outputting ofthe neural stimulus control signal 1310 and starts outputting of theaudio output signal in response to receipt of audio input signal 1414.In another aspect, prioritization circuitry 1416 automatically declinesaudio input signal 1414 if the neural stimulus is currently beingdelivered. In another aspect, prioritization circuitry 1416 provides forcircuitry for outputting the audio output signal simultaneously withneural stimulus control signal 1310. In another aspect prioritizationcircuitry 1416 provides for switching between outputting the audiooutput signal and outputting neural stimulus control signal 1346.Switching may occur in response to a user input received via user input1362, or in response to sensor input received, for example, viasecondary signal input 1360. In an aspect, prioritization circuitry 1416performs switching between outputting the audio output signal andoutputting neural stimulus control signal 1310 according to a schedule(stored, e.g., in memory 1336) in response to input from clock/timer1386. In an aspect, prioritization circuitry 1416 switches betweenoutputting the audio output signal and outputting the neural stimuluscontrol signal responsive to receipt of the audio input signal 1414 froma telecommunication network. Prioritization circuitry 1416 may beconfigured to give higher priority to outputting of the neural stimuluscontrol signal than to outputting of the audio output signal, or to givehigher priority to outputting of the audio output signal than tooutputting of the neural stimulus control signal. The priority of thesignals may be determined by the preference of the subject. For example,the subject may consider it a higher priority to receive a phone callvia his or her mobile phone than to continue received of a neuralstimulation, and therefore may configure system 1300 so that neuralstimulation is discontinued when a phone call is received.Alternatively, the subject may prefer that a neural stimulation sessionnot be interrupted, and may configure system 1300 such that no phonecalls will be received while neural stimulation is taking place. Inother aspects, the subject may provide an input at user interface 1214(e.g., by pressing a button) to switch between receiving neuralstimulation and listening to music, as preferred. In another aspect,system 1300 is configured to deliver neural stimulation in combinationwith music.

FIG. 14 is a flow diagram of a method 1450 relating to use of a systemincluding a personal computing device, as illustrated in FIG. 13. Method1450 includes receiving a neural activity signal at a personal computingdevice, the neural activity signal indicative of a physiological statusof a subject, as indicated at 1452. In addition, method 1450 includesdetermining a neural stimulus control signal based at least in part onthe neural activity signal, as indicated at 1454, and outputting theneural stimulus control signal from the personal computing device to aneural stimulation device including an external neural stimulatorconfigured to be carried on a pinna of the subject, wherein the neuralstimulus control signal is configured to control delivery of a neuralstimulus by the external neural stimulator, the neural stimulusconfigured to activate at least one sensory nerve fiber innervating atleast a portion of the pinna, as indicated at 1456. In an aspect,determining the neural stimulus control signal includes determining astimulation pattern. In various aspect, method 1450 includes additionalsteps, relating to the system functions described in greater detail inconnection with FIG. 13. For example, in an aspect, method 1450 includesproviding a report to at least one recipient, as indicated at 1458. Inan aspect, method 1450 includes determining a secondary stimulus controlsignal adapted to control delivery of a secondary stimulus to thesubject, and delivering the secondary stimulus control signal to asecondary stimulator, as indicated at 1460. For example, in an aspect,the secondary stimulator includes a game device, and the secondarystimulus control signal controls operation of the game device. Inanother aspect, the secondary stimulator includes computing systemconfigured to deliver a virtual therapist experience, and the secondarystimulus control signal controls operation of the virtual therapist. Inanother aspect, the secondary stimulus includes an interactive activitydelivered via a computing device, and the secondary stimulus controlsignal controls operation of the computing device.

In an aspect, method 1450 includes receiving a secondary input signal atthe personal computing device and determining the neural stimuluscontrol signal based at least in part on the secondary input signal, asindicated at 1462. For example, in an aspect the secondary input signalis indicative of a user input provided spontaneously by subject. Othersecondary input signals are described herein above.

In an aspect, method 1450 includes presenting a recommendation to thesubject, as indicated at 1464. Method 1450 may also include receivingthe recommendation at the personal computing device, as described abovein connection with FIG. 13.

In an aspect, method 1450 includes receiving a patch or update at thepersonal computing device, the patch or update relating to operation ofthe neural stimulation device, as indicated at 1466. In an aspect, thepatch or update is for software installed on the personal computingdevice. In another aspect, the patch or update is for software installedon the neural stimulation device, in which case method 1450 may alsoinclude sending the patch or update to the neural stimulation device.

In an aspect, method 1450 includes updating a configuration of at leastone of the neural stimulation device and the personal computing device,the configuration relating to operation of the neural stimulationdevice, as indicated at 1468. As discussed above, the configuration isupdated based on at least one instruction. In another aspect, theconfiguration is updated based on at least one recommendation,responsive to receipt of an input regarding acceptance of therecommendation by the subject or a caregiver of the subject.

In an aspect, method 1450 includes presenting information to the subjectvia a user interface, as indicated at 1470. The method may also includechanging or discontinuing the presenting of information to the subjectvia the user interface in response to an input signal. In an aspect,method 1450 includes modulating the neural stimulus control signal inresponse to an override signal, as indicated at 1472.

In an aspect, method 1450 includes receiving a position signalindicative of the position of the external neural stimulator withrespect to the pinna of the subject, as indicated at 1474. Method 1450may also include delivering a notification to the subject indicatingthat external neural stimulator should be repositioned. Other methodaspects are discussed in connection with FIG. 13.

FIG. 15 is a block diagram of a computer program product 1500 forimplementing a method as described in connection with FIG. 14. Computerprogram product 1500 includes a signal-bearing medium 1502 bearing oneor more instructions for receiving a neural activity signal, the neuralactivity signal indicative of a physiological status of a subject; oneor more instructions for determining a neural stimulus control signalbased at least in part on the neural activity signal; and one or moreinstructions for outputting the neural stimulus control signal to aneural stimulation device including an external neural stimulatorconfigured to be carried on a pinna of the subject, wherein the neuralstimulus control signal is configured to control delivery of a neuralstimulus by the external neural stimulator, the neural stimulusconfigured to activate at least one sensory nerve fiber innervating atleast a portion of the pinna, as indicated at 1504. Signal-bearingmedium 1502 may be, for example, a computer-readable medium 1506, arecordable medium 1508, a non-transitory signal-bearing medium 1510, ora communications medium 1512, examples of which are described hereinabove.

FIG. 16 is a block diagram of a system 1600 including a personalcomputing device 1602 and external neural stimulator 1604, whichcomprises a part of neural stimulation device 1606 and neuralstimulation system 1608. Personal computing device 1602 is as describedgenerally in connection with FIG. 12. In an aspect, a system 1600includes personal computing device 1602 including physiological activityinput circuitry 1610 for receiving a physiological activity signal 1612at personal computing device 1062. Physiological activity signal 1612 issensed by physiological sensor 1614 in neural stimulation system 1608,and is indicative of a physiological status of a subject. Physiologicalsensor 1614 can be any of various types of physiological sensors, e.g.,as described in connection with physiological sensor 758 in FIG. 7. Invarious aspects, physiological activity signal 1612 is representative ofa heart rate (and in some cases heart rate rhythm variability), a bloodpressure, perspiration, skin conductivity, respiration, pupil dilation,digestive tract activity, or piloerection. In some aspects,physiological activity signal 1612 is a neural activity signal, such asan electroencephalographic or electrooculographic signal. Physiologicalactivity signal 1612 may be an electromyographic signal (indicative ofmuscle activity of the subject) or an electrocardiographic signal(indicative of cardiac activity of the subject). Physiological activitysignal 1612 may be an unprocessed physiological signal, or physiologicalactivity signal 1612 may have been subjected to various types andamounts of signal processing, and/or analysis (including, but notlimited to filtering, amplification, analog to digital conversion,signal averaging, conversion from time to frequency domain, featureextraction, and so forth). Physiological activity signal 1612 mayinclude activity sensed from one or more physiological sensors 1614.Physiological activity signal 1612 may include information derived fromor associated with the sensed physiological signal, and may include orbe accompanied by additional information that identifies the type ofsignal, type of processing to which the signal has been subject, dataformatting, device settings used during acquisition of the physiologicalsignal, etc. Personal computing device 1602 also includes neuralstimulus control signal determination circuitry 1616 for determiningneural stimulus control signal 1618 based at least in part onphysiological activity signal 1612. Neural stimulus control signal 1618is configured to control delivery of a neural stimulus by externalneural stimulator 1604. In an aspect, the neural stimulus is configuredto activate at least one sensory nerve fiber innervating at least aportion of the pinna. Personal computing device 1602 also includesneural stimulus control signal output circuitry 1620 for outputtingneural stimulus control signal 1618 from personal computing device 1602to neural stimulation device 1606. Neural stimulation device 1606includes external neural stimulator 1604 configured to be carried on apinna of the subject. Personal computing device 1602 also includesoutput circuitry 1390 for presenting information to the subject via userinterface 1364 (as described herein above in connection with FIG. 13).Various elements of system 1600 are the same as like-numbered elementsof the systems shown in FIG. 12 or 13, and accordingly will not bediscussed in detail again in connection with FIG. 16. However, somecomponents of system 1600 include different and/or additional features.For example, data storage circuitry 1334 is also adapted for storingphysiological activity data 1622 representing physiological activitysignal 1612 in memory 1336. In an aspect, physiological activityprediction circuitry 1624 predicts a future physiological activitysignal based on a previous physiological activity signal. In addition,neural stimulus control signal determination circuitry 1616 determinesthe neural stimulus based on a previous physiological activity signal.Secondary stimulus determination circuitry 1344 is adapted to determinethe secondary stimulus based on physiological activity signal 1612 or aprevious physiological activity signal (e.g., stored in memory 1336). Asnoted above in connection with FIG. 13, in an aspect, secondary inputsignal 1354 is a physiological signal. It will be appreciated thatsecondary input signal 1354 in this context will be a secondaryphysiological signal, and physiological activity signal 1612 will be aprimary physiological signal. In an aspect, physiological activity inputcircuitry 1610 includes circuitry for receiving physiological activitysignal 1612 via a secure connection. In an aspect, neural stimuluscontrol signal output 1620 includes circuitry for outputting neuralstimulus control signal 1618 via a secure connection.

FIG. 17 is a flow diagram of a method 1700 relating to use of a systemas depicted in FIG. 16. In an aspect, method 1700 includes receiving aphysiological activity signal at a personal computing device, thephysiological activity signal indicative of a physiological status of asubject, as indicated at 1702; determining a neural stimulus controlsignal based at least in part on the physiological activity signal, asindicated at 1704; outputting the neural stimulus control signal fromthe personal computing device to a neural stimulation device includingan external neural stimulator configured to be carried on a pinna of thesubject, wherein the neural stimulus control signal is configured tocontrol delivery of a neural stimulus by the external neural stimulator,the neural stimulus configured to activate at least one sensory nervefiber innervating at least a portion of the pinna, as indicated at 1706;and presenting information to the subject via a user interface, asindicated at 1708. Other method aspects are discussed in connection withFIGS. 14 and 16.

FIG. 18 is a block diagram of a computer program product 1800 forimplementing a method as described in connection with FIG. 17. Computerprogram product 1800 includes a signal-bearing medium 1802 bearing oneor more instructions for receiving a physiological activity signal, thephysiological activity signal indicative of a physiological status of asubject; one or more instructions for determining a neural stimuluscontrol signal based at least in part on the physiological activitysignal; one or more instructions for outputting the neural stimuluscontrol signal to a neural stimulation device including an externalneural stimulator configured to be carried on an ear of a subject,wherein the neural stimulus control signal is configured to controldelivery of a neural stimulus by the external neural stimulator, theneural stimulus configured to activate at least one sensory nerve fiberinnervating at least a portion of the pinna; and one or moreinstructions for presenting information to the subject via a userinterface, as indicated at 1804. Signal-bearing medium 1802 may be, forexample, a computer-readable medium 1806, a recordable medium 1808, anon-transitory signal-bearing medium 1810, or a communications medium1812, examples of which are described herein above.

FIG. 19 is a block diagram of a system 1900. FIG. 19 is similar to thesystem depicted in FIGS. 13 and 16, and like-numbered system componentsdescribed in connection with these figures will not be described againin connection with FIG. 19. In an aspect, system 1900 includes apersonal computing device 1902 including physiological activity inputcircuitry 1610 for receiving a physiological activity signal at personalcomputing device 1902, the physiological activity signal 1612 indicativeof a physiological status of a subject. System 1900 also includes neuralstimulus control signal determination circuitry 1616 for determining aneural stimulus control signal 1618 based at least in part onphysiological activity signal 1612. In addition, system 1900 includesneural stimulus control signal output circuitry 1620 for outputtingneural stimulus control signal 1618 from personal computing device 1902to neural stimulation device 1904. Neural stimulation device 1904includes external neural stimulator 1604 configured to be carried on apinna of the subject, wherein neural stimulus control signal 1618 isconfigured to control delivery of a neural stimulus by the externalneural stimulator, the neural stimulus configured to activate at leastone sensory nerve fiber innervating at least a portion of the pinna.System 1900 also includes audio output circuitry 1908 for outputting anaudio output signal 1910 via an audio output 1366 of personal computingdevice 1902. In an aspect, system 1900 includes circuitry for deliveringthe audio output signal to sound source 1910 on neural stimulationdevice. In another aspect, system 1900 includes circuitry for deliveringaudio output signal 1910 to sound source 1912 that is distinct fromneural stimulation device 1904. For example, sound source 1912 may be asound source in the environment of the subject but not on the neuralstimulation device, including but not limited to a sound source on,built into, or associated with personal computing device 1902. In anaspect, system 1900 includes data storage circuitry 1334 for retrievingstored audio signal 1914 from a data storage location (memory 1336) onpersonal computing device 1902. In an aspect, system 1900 includes audioreceiver 1412 for receiving the audio input signal fromtelecommunication network 1918. For example, in various aspects, theaudio input signal is a broadcast radio signal 1920, a webcast audiosignal 1922, or a mobile phone signal 1024.

In an aspect, system 1900 includes prioritization circuitry 1416 whichprioritizes between delivery of neural stimulus and delivery of theaudio output signal, based upon system settings and/or preferences ofthe subject. For example, prioritization circuitry 1416 provides forautomatically discontinuing outputting of the neural stimulus controlsignal and starting outputting of the audio output signal in response toreceipt of the audio input signal, automatically declining the audioinput signal if the neural stimulus is currently being delivered, oroutputting the audio output signal simultaneously with the neuralstimulus control signal. In other aspects, prioritization circuitry 1416provides switching between outputting the audio output signal andoutputting the neural stimulus control signal, for example in responseto a user input or a sensor input, according to a schedule, or inresponse to receipt of an audio input signal (e.g., a phone call) from atelecommunication network. Depending on preference of the subject orother considerations, prioritization circuitry 1416 can be configured togive higher priority to outputting of the neural stimulus control signalthan to outputting of the audio output signal, or to give higherpriority to outputting of the audio output signal than to outputting ofthe neural stimulus control signal.

FIG. 20 is a flow diagram of a method 2000 relating to use of a systemas depicted in FIG. 19. In an aspect, method 2000 includes receiving aphysiological activity signal at a personal computing device, thephysiological activity signal indicative of a physiological status of asubject, as indicated at 2002; determining a neural stimulus controlsignal based at least in part on the physiological activity signal, asindicated at 2004; outputting the neural stimulus control signal fromthe personal computing device to a neural stimulation device includingan external neural stimulator configured to be carried on a pinna of thesubject, wherein the neural stimulus control signal is configured tocontrol delivery of a neural stimulus by the external neural stimulator,the neural stimulus configured to activate at least one sensory nervefiber innervating at least a portion of the pinna, as indicated at 2006;and outputting an audio output signal via an audio output of thepersonal computing device, as indicated at 2008. Other method aspectsare discussed in connection with FIGS. 14 and 19.

FIG. 21 is a block diagram of a computer program product 2100 forimplementing a method as described in connection with FIG. 20. Computerprogram product 2100 includes a signal-bearing medium 2102 bearing oneor more instructions for receiving a physiological activity signal at apersonal computing device, the physiological activity signal indicativeof a physiological status of a subject, one or more instructions fordetermining a neural stimulus control signal based at least in part onthe physiological activity signal, one or more instructions foroutputting the neural stimulus control signal from the personalcomputing device to a neural stimulation device including an externalneural stimulator configured to be carried on a pinna of the subject,wherein the neural stimulus control signal is configured to controldelivery of a neural stimulus by the external neural stimulator, theneural stimulus configured to activate at least one sensory nerve fiberinnervating at least a portion of the pinna, and one or moreinstructions for outputting an audio output signal via an audio outputof the personal computing device, as indicated at 2104. Signal-bearingmedium 2102 may be, for example, a computer-readable medium 2106, arecordable medium 2108, a non-transitory signal-bearing medium 2110, ora communications medium 2112, examples of which are described hereinabove.

FIG. 22 is a block diagram of a system 2200, which includes a personalcomputing device 2202 for use in combination with a wearable mechanicalstimulation device 2204. FIG. 22 is similar to the systems depicted inFIGS. 13, 16 and 19 and like-numbered system components described inconnection with these figures will not be described again in connectionwith FIG. 22. Personal computing device 2202 includes vibratory stimuluscontrol signal determination circuitry 2206 for determining a vibratorystimulus control signal 2208, and vibratory stimulus control signaloutput circuitry 2210 for outputting vibratory stimulus control signal2208 to wearable mechanical stimulation device 2204. Wearable mechanicalstimulation device 2204 includes a vibratory mechanical stimulator 1002configured to be carried on a pinna of a subject, wherein the vibratorystimulus control signal is configured to control delivery of a vibratorystimulus by the vibratory mechanical stimulator 1002, the vibratorystimulus configured to activate at least one mechanoreceptor with areceptive field on at least a portion of the pinna. In an aspect,wearable mechanical stimulation device 2204 is a wearable neuralstimulation device 1000 of the type discussed in connection with FIG.10, and can be considered a variant of wearable neural stimulationdevice 1202 depicted and discussed in connection with FIG. 12. Inaddition, in various aspects system 2200 includes additional componentssuch as are included in neural stimulation system 1200 described inconnection with FIGS. 7, 10 and/or 12, including, but not limited to,sensor 1018 for detecting input signal 1354, user interface 1221,position sensor 864, secondary stimulator 818, and sound source 856.Personal computing device 2202 can be any of the various types ofpersonal computing devices described in connection with FIG. 12, forexample, a personal digital assistant, a personal entertainment device,a mobile phone, a laptop computer, a table personal computer, a wearablecomputing device, a networked computer, a computing system comprised ofa cluster of processors, a computing system comprised of a cluster ofservers, a workstation computer, or a desktop computer. Data storagecircuitry 1334 including memory 1336 on personal computing device 2202can be used to store data, instructions, parameters, as describedelsewhere herein, including but not limited to stimulation patterns 2212a, 2212 b, and 2212 c representing vibratory mechanical stimuli to bedelivered under the control of vibratory stimulus control signal 2208.In an aspect, vibratory stimulus control signal 2208 is configured tocause delivery of one of a plurality of pre-programmed stimulationpatterns, e.g., selected from stimulation patterns 2212 a, 2212 b, and2212 c stored in memory 1336. In an aspect, vibratory stimulus controlsignal 2208 is determined by vibratory stimulus control signaldetermination circuitry 2206. In various aspects, vibratory stimuluscontrol signal determination circuitry 2206 includes amplitudedetermination circuitry 2214, frequency determination circuitry 2216,waveform determination circuitry 2218, pattern determination circuitry2220, or duration determination circuitry 2222 for determining variousaspects of the vibratory stimulus control signal 2208, which determinesthe mechanical stimulus delivered by vibratory mechanical stimulator1002. If position signal 2224 from position sensor 864 indicates thatvibratory mechanical stimulator 1002 is not properly positioned on theear of the subject, a notification is provided to the subject, e.g., vianotification circuitry 1406, instructing the subject to repositionvibratory mechanical stimulator 1002.

FIG. 23 is a flow diagram of a method 2300 involving the use of a systemas depicted in FIG. 22. In an aspect, method 2300 includes determining avibratory stimulus control signal with stimulation control circuitry ina personal computing device, as indicated at 2302; and outputting thevibratory stimulus control signal from the personal computing device toa wearable mechanical stimulation device including a vibratorymechanical stimulator configured to be carried on a pinna of a subject,wherein the vibratory stimulus control signal is configured to controldelivery of a vibratory stimulus by the vibratory mechanical stimulator,the vibratory stimulus configured to activate at least onemechanoreceptor with a receptive field on at least a portion of thepinna, as indicated at 2304.

FIG. 24 is a block diagram of a computer program product 2400 forimplementing a method as described in connection with FIG. 23. Computerprogram product 2400 includes a signal-bearing medium 2402 bearing oneor more instructions for determining a vibratory stimulus control signalconfigured to control delivery of a vibratory stimulus by a vibratorymechanical stimulator, the vibratory stimulus configured to activate atleast one mechanoreceptor with a receptive field on at least a portionof a pinna of a subject, and one or more instructions for outputting thevibratory stimulus control signal to a wearable mechanical stimulationdevice including the least one vibratory mechanical stimulator, asindicated at 2404. Signal-bearing medium 2402 may be, for example, acomputer-readable medium 2406, a recordable medium 2408, anon-transitory signal-bearing medium 2410, or a communications medium2412, examples of which are described herein above.

In some aspects, wearable neural stimulation devices and systems asdescribed herein above are used in combination with remote systems. Forexample, FIGS. 2A and 2B illustrate a neural stimulation system used incombination with remote system 26, via communication network 218. FIG.12 depicts communication between wearable neural stimulation device 1202and/or personal computing device 1204, which form neural stimulationsystem 1200, and remote system 1224. In addition, as shown in FIG. 13,information may be transmitted to personal computing device 1302 from aremote system, including, for example, recommendation 1372, patch/update1374, or instruction 1384. FIG. 25 provides greater detail regardingsuch a remote system 2500. Remote system 2500 includes computing system2502. Computing system 2502 includes identification circuitry 2504 forreceiving identifying information 2506 identifying at least one of asubject 2508 and a neural stimulation device 2510 associated withsubject 2508. Neural stimulation device 2510 is a neural stimulationdevice configured to be carried on an ear of a subject and including anexternal neural stimulator 2512. System 2502 includes recommendationcircuitry 2520 for providing a recommendation 2522 relating to atreatment regimen to subject 2508, where the treatment regimen includesdelivery of a neural stimulus to the subject with external neuralstimulator 2512, the neural stimulus configured to activate at least onesensory nerve fiber innervating skin on or in the vicinity of the ear ofthe subject. In an aspect, recommendation circuitry 2520 uses a databaseto generate recommendations for combinations of treatments in thetreatment regimen, for example in a manner similar to that described inU.S. Pat. No. 7,801,686 granted Sep. 21, 2010 to Hyde et al.; U.S. Pat.No. 7,974,787 granted Jul. 5, 2011 to Hyde et al.; U.S. Pat. No.8,876,688 granted Nov. 4, 2014 to Hyde et al.; U.S. Patent Publication20090269329 to Hyde et al., dated Oct. 29, 2009; U.S. Patent Publication20090271009 to Hyde et al. dated Oct. 29, 2009; and U.S. PatentPublication 20090271376 to Hyde et al. dated Oct. 29, 2009, each ofwhich is incorporated herein by reference.

In various aspects, neural stimulation device 2510 is a neuralstimulation device of any of the various types described herein, e.g.,in connection with any of FIG. 7, 10, or 12. In an aspect recommendation2522 is sent to, and identifying information 2506 is received from, alocal system 2524. Local system 2524 includes neural stimulation device2510 and other components at the location of subject 2508, including butnot limited to a secondary stimulator 2526, at least one sensor 2528(e.g., an environmental sensor 2530, a physiological sensor 2532, orother sensor as discussed herein above). In an aspect, local system 2524includes personal computing device 2534. Personal computing device 2534may include, for example, at least one of a personal digital assistant,a personal entertainment device, a mobile phone, a laptop computer, atablet personal computer, a wearable computing device, a networkedcomputer, a workstation computer, and a desktop computer, as discussedherein above. In an aspect, recommendation 2522 is presented to subject2508 via a user interface of personal computing device 2534, forexample, and acceptance or rejection of the recommendation entered via auser interface of personal computing device 2534 and transmitted asacceptance/rejection signal 2536 to remote computing system 2502.

Secondary stimulator 2526, sensor 2528, and personal computing device2534 are as described herein above, e.g., in connection with at leastFIGS. 7 and 12. Signals containing information, instructions, data, etc.may be sent between neural stimulation device 2510 and computing system2502 directly, or information may be sent between computing system 2502and personal computing device 2534, and then between personal computingdevice 2534 and neural stimulation device 2510. Transmission of signals(information, instructions, data, etc.) between computing system 2502and local system 2524 may be via wired or wireless communication links,e.g., via computer or communication networks. In an aspect, computingsystem 2502 is part of a computing network from which it receivesinformation 2536 from various parties and/or entities, including but notlimited to social media 2540, social media contacts 2542, peers 2544, orrole models 2546 of subject 2508, insurance companies, service providers(e.g., medical care providers or companies providing various health orwellness related services), and computation-based system associated withsuch service providers, for example.

Computing system 2502 includes one or more computing device, asdescribed generally in connection with FIG. 8. In an aspect, computingsystem 2502 includes update generation circuitry 2560 for generatingpatch/update 2562 which is sent to local system 2524, for updatingsoftware on either personal computing device 2534 or neural stimulationdevice 2510. In an aspect, computing system 2504 includes secondarystimulus determination circuitry 2564 for determining a secondarystimulus to be delivered in combination with the neural stimulus, e.g.,by secondary stimulator 2526. The secondary stimulus may be any ofvarious types of stimuli, as described herein above. In an aspect,computing system 2502 includes data storage circuitry 2566, which invarious aspects stores information regarding, e.g., one or morestimulation patterns 2570, subject response information 2572 received,e.g., from local system 2524, treatment regimen information 2574, or oneor more report 2576. In an aspect, report 2576 is generated by reportingcircuitry 2578 and stored in data storage circuitry 2566 in addition to,or as an alternative to, providing report 2576 to a recipient.

FIG. 26 provides greater detail regarding several aspects of FIG. 25 ofinformation handled by system 2500, specifically information included inidentifying information 2506, recommendation 2522, and treatment regimeninformation 2574.

In various aspects, identifying information 2506 includes deviceinformation 2602 pertaining to the neural stimulation device 2510, orsubject information 2610 pertaining to the subject. Device information2602 includes, for example, device type information 2604, device serialnumber 2606, or device inventory number 2608). Subject information 2610includes, for example, a name of the subject 2612, a user name 2614associated with the subject, an email address 2616 associated with thesubject, a subject identification 2618 (e.g., identification number,code or the like), or biometric information 2620 associated with thesubject. In various aspects, subject identification 2618 can be input bythe subject via a user input, read with a bar-code or RFID reader,received with an RF receiver, etc.

Recommendation 2522 may include one or more recommendations for variousaspects of device and system configuration for delivery of neuralstimulation, and for one or more additional stimuli or experiences to bepresented to or experienced by the subject in association with theneural stimulus. In various aspects, recommendation 2522 is for aconfiguration of the neural stimulus 2622 (e.g., stimulus amplitude2624, frequency 2626, duration 2628, waveform 2630, or delivery pattern2632). In various aspects, recommendation 2522 is for a secondarystimulus 2632 to be delivered in association with the neural stimulus.In various aspects, secondary stimulus 2632 includes music, an auditorystimulus, a video stimulus, a tactile stimulus, a haptic stimulus, anolfactory stimulus, a pharmaceutical, a nutraceutical, a secondaryneural stimulus, an experience (including, but not limited to a virtualreality experience, a game experience, a virtual therapist experience,an augmented reality experience, and/or an interactive experience). Invarious aspects, recommendation 2522 is for a product 2634, a service2636, an activity 2638, an experience 2640, or an organization 2642. Therecommendation may be for multiple experiences. In an aspect, therecommendation specifies a pattern of delivery of the experience(s). Itwill be appreciated that not all secondary stimuli recommended for usein conjunction with a neural stimulus are delivered by the neuralstimulation system. Recommendations (e.g., for a product, service,experience, or organization) can be presented to the subject via thepersonal computing device in the form of a link to a relevant website,so that the subject may conveniently access the recommended product,service, experience, or organization, which the subject does, asdesired.

Treatment regimen information 2574 includes, for example, neuralstimulus information 2650 regarding the neural stimulus, secondarystimulus information 2652 regarding a secondary stimulus delivered inassociation with the neural stimulus, information 2654 regarding asecondary data signal, which may specifically include neural sensorsignal information 2656, physiological sensor signal information 2658,environmental sensor signal information 2660, motion sensor information2662 or location sensor information 2664.

FIG. 27 is a flow diagram of a method 2700 carried out in connectionwith a system as depicted in FIG. 25 for providing recommendations to asubject. In an aspect, a method 2700 includes receiving identifyinginformation at a computing system (e.g., computing system 2502 in FIG.25), the identifying information identifying at least one of a subjectand a neural stimulation device associated with the subject, the neuralstimulation device configured to be carried on an ear of a subject andincluding an external neural stimulator, as indicated at 2702; andtransmitting a recommendation relating to a treatment regimen from thecomputing system to a personal computing device used by the subject(e.g., personal computing device, the treatment regimen includingdelivery of a neural stimulus to the subject with the external neuralstimulator, the neural stimulus configured to activate at least onesensory nerve fiber innervating skin on or in the vicinity of the ear ofthe subject, as indicated at 2704.

In an aspect, receiving the identifying information at the computingsystem includes receiving information transmitted from the personalcomputing device. In an aspect, receiving the identifying information atthe computing system includes receiving information transmitted via acomputing network. In an aspect, receiving the identifying informationat the computing system includes receiving information transmitted via awireless network. In an aspect, providing the recommendation relating tothe treatment regimen to the subject includes transmitting therecommendation to a personal computing device, e.g., via a computingnetwork or a wireless network.

In an aspect, the recommendation is received at the computing systemfrom a medical care provider. In another aspect, the recommendation isgenerated at the computing system, e.g., by recommendation circuitry2520 as shown in FIG. 25. The recommendation can be generated based onvarious types of information: for example, information regarding aresponse of the subject to a past treatment regimen (subject responseinformation 2572 in FIG. 25); information obtained via social media(e.g., information 2536 in FIG. 25) which may include, for example,information regarding one or more preferences of one or more socialmedia contacts, peers, or role models of the subject); information froman insurance company; or information from a service provider. In anaspect, generating the recommendation includes generating therecommendation with a computation-based system 2552 (e.g., an artificialintelligence, machine learning system, or search engine based on adata-driven technique). In an aspect, generating the recommendationincludes generating the recommendation based on a predicted response ofthe subject to a treatment regimen.

In an aspect, method 2700 includes receiving information regardingwhether the subject has accepted or rejected the recommendation. In anaspect, method 2700 includes receiving a credential showing that thesubject is an authorized user of the personal computing device. Forexample, the credential may include a password, a PIN, a biometricfeature, or a card authentication, and/or a credential showing that thepersonal computing device is an authorized device.

In an aspect, method 2700 includes storing at least one parameter of theneural stimulus in a data storage location associated with the computingsystem (e.g., with data storage circuitry 2566 of computing system2502).

In aspect, the recommendation relates to at least one parameter of theneural stimulus, for example, an amplitude, frequency, waveform, orduration of delivery of the neural stimulus, or stimulation pattern fordelivery of the neural stimulus. The stimulation pattern may be, forexample, a preprogrammed pattern, a continuous pattern, an intermittentpattern, a time-varying pattern, and/or a pulsed pattern. In an aspect,the recommendation specifies a selection of one of multiple stimulationpatterns.

In an aspect, receiving the identifying information at the computingsystem includes receiving information transmitted from the personalcomputing device.

In an aspect, method 2700 includes transmitting a report relating to thetreatment regimen to at least one recipient. In an aspect, the at leastone recipient includes, for example, the subject, a caregiver of thesubject, at least one social media contact of the subject, at least onepeer of the subject, at least one medical care provider, or at least oneinsurance provider. In an aspect, the recipient is a computing system,e.g. a computing system used for storing and/or processing healthcareinformation. In some cases the report is anonymized, e.g., to preservethe privacy of the subject. The report may include demographicinformation pertaining to the subject, but not personal identifyinginformation pertaining to the subject, for example. In an aspect,transmitting the report includes transmitting the report to the personalcomputing device. The report may include, for example, a neural stimuluscontrol signal, a determined compliance of the subject with thetreatment regimen, a determined efficacy of the treatment regimen, oneor more system settings for controlling delivery of the neural stimulus,data retrieved from a data storage location associated with thecomputing system, and/or information regarding a secondary stimulusdelivered in association with the neural stimulus. Compliance of thesubject and/or efficacy of the treatment regimen may be determined byquestioning the subject directly, by questioning another party, such asa caregiver, or by making a determination from measured physiologicalparameters of the subject.

In an aspect, method 2700 includes receiving a report relating to thetreatment regimen from the personal computing device. In an aspect,method 2700 includes storing information relating to the treatmentregimen in a data storage location associated with the computing system,e.g., treatment regimen information 2574 as described in connection withFIGS. 15 and 26.

In an aspect, method 2700 includes receiving information at thecomputing system regarding a previously delivered treatment regimen. Inaddition, the method may include receiving information at the computingsystem regarding a response of subject to the previously deliveredtreatment regimen.

In an aspect, method 2700 includes sending a patch or update to apersonal computing device from the computing system. The patch or updatemay be for software installed on the personal computing device, or forsoftware installed on the external neural stimulator.

In an aspect, method 2700 includes generating an update for theconfiguration of the neural stimulus. This may be done based on aresponse of the subject to a previous treatment regimen, based on anenvironmental factor, or based on motion or location of the subject. Inan aspect, the update is generated automatically e.g., when it isdetermined that an update is needed (based on a subject response orsensed environmental factor). In another aspect, the update is generatedbased upon acceptance of a recommendation for the update by the subject.

FIG. 28 is a block diagram of a computer program product 2800 forimplementing a method as described in connection with FIG. 27. Computerprogram product 2800 includes a signal-bearing medium 2802 bearing oneor more instructions for receiving identifying information identifyingat least one of a subject and a neural stimulation device associatedwith the subject, the neural stimulation device configured to be carriedon an ear of a subject and including an external neural stimulator, andone or more instructions for providing a recommendation relating to atreatment regimen to the subject, the treatment regimen includingdelivery of a neural stimulus to the subject with the external neuralstimulator, the neural stimulus configured to activate at least onesensory nerve fiber innervating skin on or in the vicinity of the ear ofthe subject, as indicated at 2804. Signal-bearing medium 2802 may be,for example, a computer-readable medium 2806, a recordable medium 2808,a non-transitory signal-bearing medium 2810, or a communications medium2812, examples of which are described herein above.

FIG. 29 depicts an embodiment of a system 2900 for delivering neuralstimulation in combination with providing a therapeutic secondarystimulus. System 2900 includes securing member 400, of the type depictedin FIGS. 4A and 4B, with an ear canal insert 416 including a heart ratesensor (not shown in FIG. 29), and stimulating electrodes 414 a and 414b, positioned to stimulate pinna 2902 of subject 2904. System 2900 alsoincludes mobile phone 2906, configured with application software 2908.Mobile phone 2906 and application software 2908 together form at leastphysiological activity input circuitry 2910, secondary signal input2912, neural stimulus control signal determination circuitry 2914,secondary stimulus determination circuitry 2916, and reporting circuitry2918. Mobile phone 2906 along with application software 2908 form apersonal computing device, which includes a variety of circuitry (notall of which is depicted in FIG. 29), e.g. as depicted and described inconnection with FIG. 16.

Neural stimulus control signal determination circuitry 2914 is used togenerate neural stimulus control signal 2920, which drives delivery of aneural stimulus via electrodes 414 a and 414 b. Secondary stimulusdetermination circuitry 2916 is used to generate secondary stimuluscontrol signal 2922, which controls delivery of the therapeuticsecondary stimulus while subject 2904 is receiving stimulation deliveredto pinna 2902. In the example of FIG. 29, the therapeutic secondarystimulus is provided via digital media, in the form of a therapyapplication that provides cognitive training and therapy. The therapyapplication also performs mental health monitoring. In an aspect, thetherapy application includes an interactive survey 2924 displayed ontouchscreen 2926 of mobile phone 2906. The survey asks subject 2904questions designed, for example, to assess the subject's mental oremotional state (“Rate how you feel today”), identity factorscontributing to or relating to the subject's mental or emotional state(“Did you sleep well last night?”), and guide the subject towardpositive and/or constructive thought patterns (“What did you enjoytoday?”). Subject 2904 provides responses (user input 2930) to thequeries via touchscreen 2926, which are received by secondary signalinput 2912. In addition, or as an alternative, the therapy applicationmay provide a therapeutic secondary stimulus that includes music orguided meditation, delivered via touchscreen 2926 and/or a speaker inear canal insert 416.

Heart rate 2932, sensed with a heart rate sensor (for example an ECGsensor or pulse oximeter sensor) in ear canal insert 416, is provided tophysiological activity input circuitry 2910. The subject's heart rate ismonitored during delivery of neural stimulation in combination with thetherapeutic secondary stimulus, to track the effect of the stimulationand therapy over time. Amount of heart rate variability and duration ofheart variability and/or changes in heart rate variability over time maybe monitored. Heart rate variability is an indicator of the balancebetween sympathetic and parasympathetic tone. Increased hear ratevariability is associated with reduced inflammation and anxiety. Inaddition, the physiologic data can be coupled with how the subjectinteracts with the program. In an aspect, one or both of neural stimuluscontrol signal 2920 and secondary stimulus control signal 2922 aremodified (by neural stimulus control signal determination circuitry 2914and secondary stimulus determination circuitry 2916, respectively), inresponse to heart rate 2932 and user input 2930. Physiological dataregarding the subject's heart rate as well as data regarding interactionof subject 2904 with application software 2908 can be included in report2934 which can be sent to the subject's medical care provider orpsychologist via network 2936. Detection of a heart rate indicative ofan unsafe condition due to the neural stimulation results indiscontinuation or modulation of stimulation, and transmittal of anotification to the subject's medical care provider.

The herein described subject matter sometimes illustrates differentcomponents contained within, or connected with, different othercomponents. It is to be understood that such depicted architectures aremerely exemplary, and that in fact many other architectures may beimplemented which achieve the same functionality. In a conceptual sense,any arrangement of components to achieve the same functionality iseffectively “associated” such that the desired functionality isachieved. Hence, any two components herein combined to achieve aparticular functionality can be seen as “associated with” each othersuch that the desired functionality is achieved, irrespective ofarchitectures or intermedial components. Likewise, any two components soassociated can also be viewed as being “operably connected”, or“operably coupled,” to each other to achieve the desired functionality,and any two components capable of being so associated can also be viewedas being “operably couplable,” to each other to achieve the desiredfunctionality. Specific examples of operably couplable include but arenot limited to physically mateable and/or physically interactingcomponents, and/or wirelessly interactable, and/or wirelesslyinteracting components, and/or logically interacting, and/or logicallyinteractable components.

In some instances, one or more components may be referred to herein as“configured to,” “configured by,” “configurable to,” “operable/operativeto,” “adapted/adaptable,” “able to,” “conformable/conformed to,” etc.Those skilled in the art will recognize that such terms (e.g.,“configured to”) generally encompass active-state components and/orinactive-state components and/or standby-state components, unlesscontext requires otherwise.

While particular aspects of the present subject matter described hereinhave been shown and described, it will be apparent to those skilled inthe art that, based upon the teachings herein, changes and modificationsmay be made without departing from the subject matter described hereinand its broader aspects and, therefore, the appended claims are toencompass within their scope all such changes and modifications as arewithin the true spirit and scope of the subject matter described herein.It will be understood by those within the art that, in general, termsused herein, and especially in the appended claims (e.g., bodies of theappended claims) are generally intended as “open” terms (e.g., the term“including” should be interpreted as “including but not limited to,” theterm “having” should be interpreted as “having at least,” the term“includes” should be interpreted as “includes but is not limited to,”etc.). It will be further understood by those within the art that if aspecific number of an introduced claim recitation is intended, such anintent will be explicitly recited in the claim, and in the absence ofsuch recitation no such intent is present. For example, as an aid tounderstanding, the following appended claims may contain usage of theintroductory phrases “at least one” and “one or more” to introduce claimrecitations. However, the use of such phrases should not be construed toimply that the introduction of a claim recitation by the indefinitearticles “a” or “an” limits any particular claim containing suchintroduced claim recitation to claims containing only one suchrecitation, even when the same claim includes the introductory phrases“one or more” or “at least one” and indefinite articles such as “a” or“an” (e.g., “a” and/or “an” should typically be interpreted to mean “atleast one” or “one or more”); the same holds true for the use ofdefinite articles used to introduce claim recitations. In addition, evenif a specific number of an introduced claim recitation is explicitlyrecited, those skilled in the art will recognize that such recitationshould typically be interpreted to mean at least the recited number(e.g., the bare recitation of “two recitations,” without othermodifiers, typically means at least two recitations, or two or morerecitations). Furthermore, in those instances where a conventionanalogous to “at least one of A, B, and C, etc.” is used, in generalsuch a construction is intended in the sense one having skill in the artwould understand the convention (e.g., “a system having at least one ofA, B, and C” would include but not be limited to systems that have Aalone, B alone, C alone, A and B together, A and C together, B and Ctogether, and/or A, B, and C together, etc.). In those instances where aconvention analogous to “at least one of A, B, or C, etc.” is used, ingeneral such a construction is intended in the sense one having skill inthe art would understand the convention (e.g., “a system having at leastone of A, B, or C” would include but not be limited to systems that haveA alone, B alone, C alone, A and B together, A and C together, B and Ctogether, and/or A, B, and C together, etc.). It will be furtherunderstood by those within the art that typically a disjunctive wordand/or phrase presenting two or more alternative terms, whether in thedescription, claims, or drawings, should be understood to contemplatethe possibilities of including one of the terms, either of the terms, orboth terms unless context dictates otherwise. For example, the phrase “Aor B” will be typically understood to include the possibilities of “A”or “B” or “A and B.”

With respect to the appended claims, those skilled in the art willappreciate that recited operations therein may generally be performed inany order. Also, although various operational flows are presented in asequence(s), it should be understood that the various operations may beperformed in other orders than those which are illustrated, or may beperformed concurrently. Examples of such alternate orderings may includeoverlapping, interleaved, interrupted, reordered, incremental,preparatory, supplemental, simultaneous, reverse, or other variantorderings, unless context dictates otherwise. Furthermore, terms like“responsive to,” “related to,” or other past-tense adjectives aregenerally not intended to exclude such variants, unless context dictatesotherwise.

While various aspects and embodiments have been disclosed herein, otheraspects and embodiments will be apparent to those skilled in the art.The various aspects and embodiments disclosed herein are for purposes ofillustration and are not intended to be limiting, with the true scopeand spirit being indicated by the following claims.

What is claimed is:
 1. A system comprising: circuitry for receiving aneural activity signal, the neural activity signal indicative of aphysiological status of a subject; circuitry for determining a neuralstimulus control signal based at least in part on the received theneural activity signal; and circuitry for outputting the neural stimuluscontrol signal to a neural stimulation device including an externalneural stimulator configured to be carried on a pinna of the subject;wherein the neural stimulus control signal is configured to controldelivery of a neural stimulus by the external neural stimulator, theneural stimulus configured to activate at least one sensory nerve fiberinnervating at least a portion of the pinna. 2.-151. (canceled)
 152. Amethod comprising: receiving a neural activity signal at a personalcomputing device, the received neural activity signal indicative of aphysiological status of a subject; determining a neural stimulus controlsignal based at least in part on the received neural activity signal;and outputting the neural stimulus control signal from the personalcomputing device to a neural stimulation device including an externalneural stimulator configured to be carried on a pinna of the subject;wherein the neural stimulus control signal is configured to controldelivery of a neural stimulus to the subject by the external neuralstimulator, the neural stimulus configured to activate at least onesensory nerve fiber innervating at least a portion of the pinna.153.-178. (canceled)
 179. The method of claim 152, including providing areport to at least one recipient. 180.-201. (canceled)
 202. The methodof claim 152, including determining a secondary stimulus control signaladapted to control delivery of a secondary stimulus to the subject anddelivering the secondary stimulus control signal to a secondarystimulator. 203.-217. (canceled)
 218. The method of claim 152, includingreceiving a secondary input signal at the personal computing device anddetermining the neural stimulus control signal based at least in part onthe secondary input signal. 219.-245. (canceled)
 246. The method ofclaim 152, including presenting a recommendation to the subject.247.-264. (canceled)
 265. The method of claim 246, including receivinguser input from the subject regarding acceptance or rejection of therecommendation.
 266. The method of claim 152, including receiving apatch or update at the personal computing device, the patch or updaterelating to operation of the neural stimulation device. 267.-269.(canceled)
 270. The method of claim 152, including updating aconfiguration of at least one of the neural stimulation device and thepersonal computing device, the configuration relating to operation ofthe neural stimulation device. 271.-294. (canceled)
 295. The method ofclaim 152, including presenting information to the subject via a userinterface. 296.-301. (canceled)
 302. The method of claim 295, includingreceiving a credential showing that the subject is an authorized userand presenting the information to the subject via the user interfaceonly following receipt of the credential showing that the subject is anauthorized user. 303.-309. (canceled)
 310. The method of claim 295,including changing or discontinuing the presenting of information to thesubject via the user interface in response to an input signal. 311.-314.(canceled)
 315. The method of claim 152, including modulating the neuralstimulus control signal in response to an override signal. 316.-321.(canceled)
 322. The method of claim 152, including receiving a positionsignal indicative of the position of the external neural stimulator withrespect to the pinna of the subject. 323.-331. (canceled)
 332. Themethod of claim 152, including outputting an audio output signal via anaudio output of the personal computing device, wherein the audio outputsignal is configured for driving delivery of sound to the ear of thesubject via a sound source. 333.-349. (canceled)
 350. A computer programproduct comprising: a non-transitory signal-bearing medium bearing oneor more instructions for receiving a neural activity signal, the neuralactivity signal indicative of a physiological status of a subject; oneor more instructions for determining a neural stimulus control signalbased at least in part on the neural activity signal; and one or moreinstructions for outputting the neural stimulus control signal to aneural stimulation device including an external neural stimulatorconfigured to be carried on a pinna of the subject; wherein the neuralstimulus control signal is configured to control delivery of a neuralstimulus by the external neural stimulator, the neural stimulusconfigured to activate at least one sensory nerve fiber innervating atleast a portion of the pinna. 351.-522. (canceled)
 523. the method ofclaim 152, including receiving the neural activity signal via at leastone of a headphone jack, a data input, a wireless receiver, a body areanetwork, a local area network, and a wide area network.
 524. The methodof claim 152, wherein determining the neural stimulus control signalincludes determining at least one of a neural stimulus amplitude, aneural stimulus frequency, a neural stimulus duration, a neural stimuluswaveform, and a stimulation pattern.
 525. The method of claim 152,wherein the neural stimulus control signal is configured to causedelivery of at least one of a continuous neural stimulus, anintermittent neural stimulus, a time-varying neural stimulus, a pulsedneural stimulus, and a neural stimulus selected from a plurality ofpre-programmed stimulation patterns.
 526. The method of claim 152,including at least one of storing data on the personal computing devicerepresenting the received neural activity signal, storing data on thepersonal computing device representing the determined neural stimuluscontrol signal, predicting future neural activity signal based on aprevious neural activity signal, determining a neural stimulus based ona previous neural activity signal, and determining a secondary stimulusbased on the neural activity signal.
 527. The method of claim 152,including at least one of receiving the neural activity signal via asecure connection and outputting the neural stimulus control signal viaa secure connection.
 528. The method of claim 179, wherein the at leastone recipient includes at least one of the subject, a medical careprovider, an insurance company, a service provider, a social mediacontact of the subject, a caregiver, and a computing system.
 529. Themethod of claim 179, wherein providing the report includes at least oneof providing the report via a user interface associated with the neuralstimulation device, providing the report via a user interface associatedwith the personal computing device, providing the report via a computingnetwork, and providing the report in anonymized form.
 530. The method ofclaim 179, wherein the report includes at least one of the neuralactivity signal, information derived from the neural activity signal,information relating to the mental or emotional state of the subject,information relating to a physiological parameter of the subject,information relating to the neural stimulus control signal, informationregarding system settings for at least one of the neural stimulationdevice and the personal computing device, stored data relating to theneural activity signal, stored data relating to the mental or emotionalstate of the subject, stored data relating to a physiological parameterof the subject, information relating to a secondary input signal, andinformation relating to a secondary stimulus.
 531. The method of claim202, wherein the secondary stimulus includes at least one of music, anauditory stimulus, a video, a tactile stimulus, a haptic stimulus, anolfactory stimulus, a pharmaceutical, a nutraceutical, and a secondaryneural stimulus.
 532. The method of claim 202, wherein the secondarystimulus control signal is adapted to control at least one of deliveryof a pharmaceutical to the subject by a drug delivery device, promptingof a user via a user interface to administer a pharmaceutical to thesubject, operation of a virtual reality system, operation of a gamedevice, delivery of a virtual therapist experience via a computingsystem, and delivery of an interactive activity via a computing device.533. The method of claim 218, wherein the secondary input signal isrepresentative of at least one of a physiological parameter of thesubject, a heart rate, a muscle activity, a blood pressure,perspiration, skin conductivity, respiration, pupil dilation, intestinalactivity, piloerection, a motion of the subject, a location of thesubject, a microbiome of the subject, a genome of the subject, anenvironmental parameter, a day length, a light level, a time, a date, atemperature, an ambient noise level, a secondary stimulus to thesubject, a user input provided by subject, a user input providedspontaneously by the subject, a user input provided by the subject inresponse to a prompt or query, and a user input provided by the subjectin response to an interactive environment.
 534. The method of claim 246,including receiving the recommendation at the personal computing device,wherein receiving the recommendation at the personal computing deviceincludes at least one of receiving the recommendation via a computingnetwork, receiving the recommendation from a medical care provider,receiving the recommendation from an insurance company, receiving therecommendation from a service provider, receiving the recommendationfrom an advisor, receiving the recommendation from a computation-basedsystem, and receiving the recommendation from a social media source.535. The method of claim 246, wherein the recommendation is based on atleast one of at least one preference of at least one social mediacontact of the subject, at least one preference of at least one peer ofthe subject, and at least one preference of at least one role model ofthe subject.
 536. The method of claim 246, wherein the recommendationrelates to at least one of a configuration of the neural stimuluscontrol signal, a secondary stimulus, a consumer product, a service, auser experience, a user activity, and an organization.
 537. The methodof claim 266, wherein the patch or update is for at least one ofsoftware installed on the personal computing device and softwareinstalled on the neural stimulation device.
 538. The method of claim270, wherein updating the configuration includes updating theconfiguration based on at least one of historical data, historical datarepresentative of at least one historical value of the neural activitysignal, historical data representative of at least one historical valueof the neural stimulus control signal, historical data representative ofat least one historical value of a secondary input signal, at least oneinstruction, at least one instruction received from a computing network,at least one instruction received via a user input device, at least oneinstruction received from a medical care provider, at least oneinstruction received from an insurance company, at least one instructionreceived from a service provider, at least one recommendation, at leastone recommendation received from an advisor, at least one recommendationreceived from a computation-based system, at least one recommendationreceived from a social media source, at least one recommendation basedon a preference of at least one social media contact of the subject, atleast one recommendation based on a preference of at least one peer ofthe subject, at least one recommendation based on a preference of atleast one role model of the subject, a user input from the subjectindicating acceptance of a recommendation by the subject, an input froma caregiver of the subject indicating acceptance of a recommendation bythe caregiver, a motion of the subject, a location of the subject, anenvironmental parameter, and a schedule.
 539. The method of claim 295,wherein the user interface includes at least one of an audio output, analphanumeric display, a graphical display, and a touch screen.
 540. Themethod of claim 295, including customizing for the subject at least oneof the information presented via the user interface and the formattingof the information presented via the user interface.
 541. The method ofclaim 295, wherein the user interface includes a graphical display, andwherein presenting the information to the subject via the user interfaceincludes at least one of presenting the information to the subject in agraphical format that mimics the graphical format of a music player,presenting the information to the subject in a graphical format thatmimics the graphical format of a mobile phone, and presenting theinformation to the subject in a graphical format that mimics thegraphical format of a familiar user interface.
 542. The method of claim302, wherein receiving the credential includes at receiving at least oneof a password, a personal identification number, a biometric feature,and a card authentication.
 543. The method of claim 310, wherein theinput signal includes at least one of a user input signal, a sensedenvironmental signal indicative of presence of another person, and atime.
 544. The method of claim 315, including at least one of receivingthe override signal via a user input device, receiving the overridesignal from a sensor responsive to sensing a presence of a person otherthan the subject in the vicinity of the subject, receiving the overridesignal from a physiological sensor indicating of an unsafe condition,and receiving the override signal from a sensor responsive to sensingthat the external neural stimulator is not properly positioned on thepinna of the subject.
 545. The method of claim 322, including deliveringa notification to the subject indicating that external neural stimulatorshould be repositioned, wherein delivering the notification to thesubject includes at least one of delivering the notification via agraphical display of the personal computing device, delivering anauditory alert, delivering a visual alert, delivering a voice message,delivering the notification via an audio output of the personalcomputing device, delivering the notification via an audio output of theneural stimulation device, storing information indicating thatstimulator is improperly positioned in a data storage location in thepersonal computing device, and storing information indicating thatstimulator is improperly positioned in a data storage location in theneural stimulation device.
 546. The method of claim 332, includingdelivering the audio output signal to at least one of a sound source onthe neural stimulation device and a sound source distinct from theneural stimulation device.
 547. The method of claim 332, including atleast one of retrieving an audio signal from a data storage location onthe personal computing device and outputting the audio output signalbased on the audio signal retrieved from the data storage location onthe personal computing device, and receiving an audio input signal froma telecommunication network and outputting the audio output signal basedon the audio input signal.
 548. The method of claim 332, including atleast one of outputting the audio output signal simultaneously with theneural stimulus control signal, switching between outputting the audiooutput signal and outputting the neural stimulus control signal, givinghigher priority to outputting of the neural stimulus control signal thanto outputting of the audio output signal, giving higher priority tooutputting of the audio output signal than to outputting of the neuralstimulus control signal, automatically discontinuing outputting of theneural stimulus control signal and starting outputting of the audiooutput signal in response to receipt of an audio input signal, andautomatically declining an audio input signal if the neural stimulus iscurrently being delivered.
 549. The computer program product of claim350, wherein the non-transitory signal bearing medium bears one or moreinstructions for receiving the neural activity signal via at least oneof a headphone jack, a data input, a wireless receiver, a body areanetwork, a local area network, and a wide area network.